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Apple Watch and AirPods Pro Are Equipped with New Health Features

The latest health features coming to Apple Watch and AirPods Pro.

Apple unveiled breakthrough sleep and hearing health features coming to Apple Watch and AirPods Pro 2 that further deliver on Apple’s commitment to health with experiences that enrich users’ lives. These new features expand across products, bringing informative and powerful ways to support users in their sleep and hearing health for conditions that impact billions globally.

Using an innovative new Breathing Disturbances metric, sleep apnea notifications come to Apple Watch, adding to the many ways Apple Watch acts as an intelligent guardian for users’ health. The sleep apnea notifications are expected to receive marketing authorization from the Food and Drug Administration (FDA) and other global health authorities soon, with availability this month in more than 150 countries and regions, including the U.S., the EU, and Japan, Apple said in a press release.

“At Apple, we believe that technology can help you live a healthier life, and we’re excited to enable incredible new health capabilities for serious conditions that affect billions of people around the world, while continuing to keep user data private,” said Sumbul Desai, M.D., Apple’s vice president of Health. “With Apple Watch, we continue to offer our users the ability to uncover important health conditions with new sleep apnea notifications. And on AirPods Pro, powerful features put users’ hearing health front and center, bringing new ways to help test for and receive assistance for hearing loss.”

A Powerful Way to Detect Signs of Sleep Apnea

Sleep is an important area of health as it impacts a person’s overall physical and mental wellbeing. Sleep apnea is a prevalent disorder in which breathing momentarily stops during sleep, preventing the body from getting enough oxygen. The condition is estimated to impact more than 1 billion people worldwide, and in most cases, goes undiagnosed. If left untreated, it can have important health consequences over time, including increased risk of hypertension, type 2 diabetes, and cardiac issues.

Related Apple Vision Pro Can Now Control Brain Implant

Breathing Disturbances is an innovative new Apple Watch metric that uses the accelerometer to detect small movements at the wrist associated with interruptions to normal respiratory patterns during sleep. Every 30 days, Apple Watch will analyze breathing disturbance data and notify users if it shows consistent signs of moderate to severe sleep apnea so they can speak to their doctor about next steps, including potential diagnosis and treatment.

The World’s First All-in-One Hearing Health Experience

Approximately 1.5 billion people around the world are living with hearing loss, according to the World Health Organization. Research has also identified links between hearing loss and impact on a person’s overall wellbeing, including dementia and social isolation.

To help users better understand their hearing health, Apple is introducing an end-to-end experience focused on prevention, awareness, and assistance.

In order to help users prevent exposure to loud environmental noise while preserving the sound signature of what they’re listening to, Hearing Protection comes to AirPods Pro. The ear tips help to provide passive noise reduction, while the H2 chip helps to actively reduce louder, more intermittent noise at 48,000 times per second. On by default across all listening modes, Hearing Protection is helpful in a variety of loud settings. Plus, with an all-new multiband high dynamic range algorithm, sounds at live events like concerts remain natural and vibrant.

Apple is also introducing an intuitive, clinical-grade hearing test based on the standard clinical approach called pure-tone audiometry that users can take themselves with their AirPods Pro and a compatible iPhone or iPad.

Users can take the convenient test in about five minutes from the comfort of their own home. The Hearing Test feature leverages advanced acoustic science and provides users with an interactive experience.

After taking the Hearing Test, the user’s hearing profile can also help to personalize the AirPods Pro listening experience for even more people, including those with little to no hearing loss who can still benefit from specific adjustments at individual frequencies.

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Neuralink's "Blindsight" Gets FDA Nod to Restore Vision

Neuralink gains "breakthrough" status for implant to help blind patients restore vision.

Elon Musk's brain-chip startup Neuralink has received FDA breakthrough device designation for Blindsight, an implant that aims to restore vision in individuals who are blind.

According to Musk, the device, called “Blindsight,” will allow people who have lost both eyes and their optic nerve to see as long as the visual cortex — the part of the brain that receives and processes visual information relayed from the eyes— is intact.

“The Blindsight device from Neuralink will enable even those who have lost both eyes and their optic nerve to see,” Musk wrote on X on Tuesday. “Provided the visual cortex is intact, it will even enable those who have been blind from birth to see for the first time.”

The FDA's breakthrough tag is given to certain medical devices that provide treatment or diagnosis of life-threatening conditions. It is aimed at speeding up development and review of devices currently under development, reports New York Post.

According to the agency's website, the "breakthrough device" program aims to "speed up development, assessment and review for premarket approval" for medical devices that treat permanent or life-threatening illnesses, provided that they follow safety criteria.

“To set expectations correctly, the vision will be at first be low resolution, like Atari graphics, but eventually it has the potential be better than natural vision and enable you to see in infrared, ultraviolet or even radar wavelengths, like Geordi La Forge,” Musk added.

Related This Wearable Lets Blind People See

Neuralink is developing a brain chip interface that can be implanted inside the skull. Founded in 2016 by Musk and a team of engineers, the company claims that this technology might eventually let crippled patients move and speak again as well as restore their vision.

The device from Neuralink contains a chip that can process and send neural signals to other devices, such as a phone or computer.
Earlier this year, Neuralink completed its first successful device implantation in a patient, who has since used the company's BCI for various applications, including playing video games and online chess.

Last year, the company received FDA approval to move from animal and human testing of its BCI device.

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Dexcom Stelo Now Available in the US

Dexcom launches Stelo, its first OTC wearable glucose biosensor, after FDA approval in March.

DexCom, the global leader in real-time continuous glucose monitoring for people with diabetes, announced today that Stelo, the first over-the-counter glucose biosensor in the U.S., is now available for purchase without a prescription via the company’s website.

Stelo is a small biosensor worn on the back of the upper arm that leverages Dexcom’s most accurate glucose sensing technology. It is specifically designed to provide the 125 million Americans 6 with Type 2 diabetes not using insulin and those with prediabetes with powerful, personalized glucose insights sent directly to a smartphone, revealing how food, exercise and sleep can affect glucose – all without painful fingersticks, Dexcom said in a press release.

“Dexcom has been at the forefront of glucose biosensing for 25 years. With the launch of Stelo, we’re defining a brand-new category and once again setting the gold standard for people to easily take control of their health,” said Jake Leach, executive vice president and chief operating officer at Dexcom. “Now, millions more have access to 24/7, easy-to-understand glucose insights that can inform their daily lifestyle choices and support behavior modification.”

The benefits of glucose biosensing have been shown when used alone, or alongside other diabetes and weight management medications. 7 Studies show the use of Dexcom glucose biosensing by people with Type 2 diabetes is associated with clinically meaningful improvement in time in range, A1c and quality of life.

Related Abbott Receives FDA Clearance for Two CGMs

“Dexcom glucose biosensors are an essential and proven tool for diabetes management – driving strong clinical outcomes regardless of medication use 9 and even potentially slowing the progression of diabetes,” said Thomas Grace, MD, head of clinical advocacy and outcomes at Dexcom. “In a world where GLP-1 use is becoming increasingly more common, glucose biosensors like Stelo can help make those medications more effective.”

Key features of Stelo

No fingersticks, ever: The only over-the-counter glucose biosensor designed for people with diabetes that doesn’t require any fingersticks.

Up to 15-day wear time and waterproof: The longest biosensor wear time on the market ‡ with the highest waterproof rating.

A personalized, easy-to-use app: Provides daily, weekly and session summary insights that can help form healthier habits.

Spike and pattern detection: The only over-the-counter glucose biosensor for people with diabetes featuring spike detection, designed to identify meaningful glucose variability as it happens so users can make informed changes.

Proven results with Dexcom glucose sensors: Using Dexcom glucose sensors like Stelo helps lower A1c for people with Type 2 diabetes and may help slow the progression of diabetes. Only Dexcom glucose sensors have been associated with significant improvements in glucose and cardiovascular risk reduction measures as early as three months.

Effortless ordering, delivered directly to your door

Stelo improves access to critical health technology for people with Type 2 diabetes not using insulin and those with prediabetes who might not have insurance coverage for prescription glucose biosensors. Stelo is currently available for purchase in the U.S. at Stelo.com and is FSA and HSA eligible.

Pay-as-you-go: Pay $99 for a single pack of two sensors (total wear time up to 30 days).
Monthly subscription: Subscribe and save 10%. Pay $89 per month for an ongoing subscription, with two sensors (total wear time up to 30 days) delivered every 30 days.

Stelo is now part of Dexcom’s overall portfolio of glucose biosensors, with a user base of more than 2.5 million people globally. The Dexcom portfolio in the U.S. consists of the Dexcom G6 and Dexcom G7 Continuous Glucose Monitoring Systems, and now Stelo, collectively designed to address the needs of people with all types of diabetes and prediabetes.

About DexCom, Inc.

DexCom, Inc. empowers people to take control of health through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, Calif., and with operations across Europe and select parts of Asia/Oceania, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers and providers, Dexcom works to simplify and improve diabetes management around the world.

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Even Realities: The Future of Digital Glasses

Revolutionary optics meet innovative software. Even Realities has pushed the boundaries of AR.

Even Realities has unveiled its highly anticipated G1 Smart Glasses, marking a new era in augmented reality (AR) innovation. The G1 promises to deliver a seamless blend of immersive digital experiences with the physical world, targeting tech enthusiasts, professionals, and gamers alike.

A Leap in AR Technology

The G1 Smart Glasses stand out with their lightweight, ergonomic design, offering users a more comfortable and versatile experience compared to previous AR glasses. Even Realities has prioritized both style and functionality, making the G1 a fashion-forward device that users can wear all day without discomfort.

Key to the G1's appeal is its crystal-clear optics and high-definition display, providing an unrivaled field of view. The smart glasses come equipped with dual HD micro-OLED displays, ensuring that both text and 3D imagery are rendered with remarkable sharpness. This feature allows users to seamlessly interact with virtual objects overlaid on their real-world surroundings.

The smart glasses also boast 6DoF (Six Degrees of Freedom) tracking, which allows for fluid and intuitive movement within AR environments. Whether you're a gamer navigating complex digital worlds or a professional utilizing augmented workspaces, the G1 promises smooth and natural interaction.

Next-Level Hardware & Software Integration

The Even Realities G1 features the latest Qualcomm Snapdragon XR2 chipset, a powerful processor specifically designed for AR and VR applications. This allows for enhanced real-time processing and rendering, enabling developers to create more complex and interactive AR environments without latency or performance dips.

Paired with its hardware prowess, the G1 runs on Even Realities OS, a proprietary operating system optimized for AR. The OS is compatible with major AR development platforms like Unity and Unreal Engine, allowing developers to bring immersive apps and games to life with ease. The device is also equipped with AI-powered voice and gesture recognition, ensuring hands-free control for a wide range of applications.

Applications in Professional and Consumer Spaces

The G1 is not just for gaming or entertainment but also aims to disrupt various industries. In the professional space, the glasses can be used for remote collaboration, design, training, and real-time data visualization. Architects, engineers, and medical professionals can benefit from the ability to visualize complex models and data overlaid on physical objects, improving decision-making and efficiency.

For consumers, the G1 promises a new dimension of interactivity in daily life. From AR-enhanced fitness workouts to immersive gaming experiences, the possibilities are limitless. Early reviews from beta testers indicate that the G1’s real-world AR integration offers one of the most lifelike and engaging experiences on the market.

Connectivity and Battery Life

The G1 Smart Glasses offer a robust wireless connectivity suite, supporting Wi-Fi 6E and Bluetooth 5.3, allowing for seamless connection to other devices, including smartphones and computers. This ensures that users can stay connected without compromising on speed or performance.

Battery life has been a significant focus for Even Realities. The G1 provides an impressive 8 hours of continuous use, making it ideal for both personal and professional applications. Fast charging ensures minimal downtime, with the device reaching 80% capacity in under an hour.

Privacy and Safety Features

Even Realities has also addressed concerns surrounding privacy and security in AR devices. The G1 includes advanced privacy settings that allow users to control what data is shared with apps and third parties. Built-in safety features like automatic environmental awareness alert users when obstacles or potential hazards are detected in their surroundings, ensuring a safe AR experience.

Conclusion

Even Realities’ G1 Smart Glasses are set to make waves in the AR world, offering a blend of style, power, and versatility that has yet to be matched. With its sleek design, high-performance hardware, and groundbreaking software features, the G1 is poised to become a frontrunner in both the consumer and professional AR markets.

The G1 Smart Glasses are expected to hit the market by late 2024, with prices starting at $1,199. Pre-orders are already open, and demand is high as tech enthusiasts eagerly anticipate the future of augmented reality.

About Even Realities

Even Realities is a leader in AR technology, known for creating innovative products that push the boundaries of digital and physical integration. The company's focus on user-friendly, high-performance devices has made it a key player in the evolving world of augmented reality.

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Shimano Receives US Patent for Cycling Shoes

U.S. patent for an innovative wireless electronic cleat system designed for cycling shoes.

The United States Patent and Trademark Office has granted Shimano a US patent for a wireless electronic cleat system for cycling shoes. As you ride, the changes the shoe's position in relation to your pedals. With the use of inputs from rider and bike sensors, it enables lateral and fore-aft positioning. These produce data that finds the ideal shoe position and moves there automatically. It is also possible to change manually.

Typically, a pedal, cleat, and shoe connect a rider to their bicycle. An "adjuster" on the sole of the shoe is present in this instance. This is equipped with the cleat, and the shoe attaches to the pedal using the conventional method. With the help of rails, this adjuster's reversible electric motor may move the shoe from front to back and left to right, reports New Atlas.

The system's primary battery is located in the pedal, and the shoe, cleat, and adjuster are all powered via a wireless system.

But why such adjustability? Because bicyclists adapt their body position to the many terrains they ride on, including varying uphill and downhill grades. This can alter the legs' pivot points and angles; if the foot's contact point can adapt to compensate, there may be mechanical benefits and improved performance.

Related Walk Faster With These Robotic Shoes

The possible performance advantages of Shimano's adjustable shoes are not yet supported by scientific data, despite their technological promise. “adjusting the anterior-posterior foot position on the pedal does not affect cycling economy in competitive cyclists pedaling at a steady-state power output eliciting approximately 90% of VT [Ventilatory Threshold],” according to a study published in 2023. The results of this study, which was probably carried out in a controlled laboratory setting, imply that the advantages of adjusting foot position may be few, or at the very least, insignificant enough to have no effect on overall performance under steady-state settings.

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Google Pixel Watch 3: Fine-Tuned for Fitness

Pixel Watch 3 uses AI to analyze fitness, sleep, and recovery, tailoring insights to each user.

Google has officially announced the Pixel Watch 3 after months of speculation and leaks. Google’s Pixel Watch has always been a fan favorite for many Pixel phone owners because it kept things within the ecosystem. In fact, Google says that users have “loved the deep integration of Pixel Watches, Pixel Buds, and Pixel phones.”

Pixel Watch 3 is available in two sizes and boasting a slimmer bezel, a brighter screen, advanced fitness training tools, better integration with other Google products and improved power management.

Similar to earlier models, the Pixel Watch 3 tracks a wearer's vitals including oxygen, skin temperature, and heart rate in addition to sleep and stress levels.

Google said these elements of health are related. Sleep and exercise levels affect recovery, and recovery affects the amount of activity a person can perform, repots MobiHealthNews.

All of that data is gathered and combined by the Pixel Watch 3 to provide users with a detailed profile that is initially targeted at runners.

The new health features are meant to assist runners in selecting their exercises and in thinking back on their progress.

Related Google: Gemini Will Outshine ChatGPT

With the help of the wearable, users may design their own workout by adding segments, assigning goals to the segments, and establishing intervals.

Using haptic and auditory signals, the wearer receives advice from the gadget as a coach while they run.

Additionally, the watch enables connectivity between devices, including Peloton and NordicTrack training equipment.

Without having to look for settings, users may manage media playback on the exercise screen and follow Google Maps offline.

Google also claims that the Pixel Watch 3 will offer the most precise heart-rate sensing available for runners thanks to recent improvements to its sensing technology.

HR monitoring uses machine learning to measure a user's heart rate and record the wearer's running form. The wearer's form and dynamics, including step cadence, stride height and length, and ground contact time, can also be analyzed by the device.

A user can see performance stats to get ideas on how to get fitter after working out. The watch also evaluates and links the intensity of a workout to the requirement for recovery.

The watch also has a feature called "loss of pulse detection" that feels for a person's pulse. The watch will notify the operator via an automated message and make a call to emergency services if no pulse is detected.  

Additionally, it enters Auto Bedtime Mode, which turns off notifications and detects when the wearer goes asleep. The watch recognizes when a user wakes up and instantly ends Bedtime Mode.

The tech giant also revealed that the Pixel 9, Pixel 9 Pro, and Pixel 9 Pro XL will come equipped with Gemini Live, an AI chatbot that uses generative intelligence. Users can converse freely with the AI chatbot using Live.

Preorders for the Google Pixel Watch 3 are open as of right now, and delivery is scheduled to begin on September 10, 2024. The price of the smaller 41mm device, which is limited to Bluetooth, is $349, while the LTE edition is $449. The cost of the bigger 45mm is $499 for LTE and $399 with Bluetooth.

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September 2024: The Revolutionary .lumen Glasses

Empowering the visually impaired with smart, award-winning technology for greater independence.

We are excited to present the .lumen glasses as our Innovation of the Month September. These cutting-edge glasses are more than just a technological gadget—they represent a breakthrough in assistive technology for people with visual impairments. The .lumen glasses combine advanced camera technology with AI-powered image recognition to detect obstacles in the environment and provide immediate auditory feedback to the wearer. This significantly enhances orientation and mobility, fundamentally transforming the daily lives of many people with visual impairments.

The .lumen glasses are not only an impressive example of technological innovation but have also garnered international recognition for their outstanding performance and social impact. They have been awarded the prestigious Red Dot Design Award for exceptional product design. Additionally, they won the CES Innovation Award, which honors groundbreaking technologies with the potential to improve our lives. These accolades highlight the groundbreaking significance of the .lumen glasses and their role as a pioneer in the development of assistive devices for the visually impaired.

In addition to their technical sophistication, the .lumen glasses are distinguished by their user-friendly design and sleek aesthetics. They are lightweight, comfortable to wear, and easily integrated into everyday life. These features make them ideal for individuals seeking discreet yet effective support in their daily activities. The .lumen glasses set new standards in assistive technology, opening up new possibilities for independence and quality of life for people with visual impairments.

About .lumen

.lumen is a pioneering company dedicated to transforming the lives of individuals with visual impairments through innovative technology. With a focus on combining advanced AI with practical design, .lumen creates cutting-edge solutions that enhance mobility, independence, and quality of life. Their commitment to excellence and social impact has positioned them as a leader in the assistive technology industry, earning them global recognition and numerous awards for their groundbreaking products.

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New Sensor Detects Diabetes and Stroke

Researchers in Singapore have developed a wearable diabetes tracker.

A new, non-invasive method may do away with the need to draw blood for testing blood glucose and cholesterol levels.

Researchers from the National University of Singapore (NUS) and the Agency for Science, Technology and Research (A*Star) have developed a stretchable, hydrogel-based sensor that can detect such biomarkers in a solid state on the skin.

The technology could be used in wearables for purposes such as chronic disease management and remote patient monitoring, reports Zhaki Abdullah in The Strait Times.

Monitoring biomarkers — chemicals found in blood or other body fluids that capture what is happening in a cell or an organism at a given moment — traditionally involves analyzing biofluids such as blood, urine and sweat. While effective, these methods come with challenges. Blood tests are invasive and inconvenient, while urine analyses can be cumbersome and lack real-time capability. Probing biomarkers from sweat, though non-invasive, is limited by the difficulty of inducing sweat in inactive individuals and the discomfort of using sweat-inducing drugs. All these pose barriers to the early diagnosis and treatment of diseases.

SEBs offer a compelling alternative. These biomarkers, which include cholesterol and lactate, are found in the stratum corneum, the outermost layer of the skin, and have shown strong correlations with diseases such as cardiovascular disease and diabetes. However, detecting these biomarkers directly has been difficult. For instance, traditional solid electrodes lack the necessary charge transport pathways to enable electrochemical sensing of SEBs.

Related Printed and Flexible Sensor Market Poised to Grow

The NUS and A*STAR research team has overcome this challenge with their novel sensor design. When the device is worn on the skin, SEBs dissolve into the ionic conductive hydrogel (ICH) layer, diffuse through the hydrogel matrix, and undergo electrochemical reactions catalyzed by enzymes at the junction between the ICH and electronically conductive hydrogel (ECH) layer. Relevant physiological data is then transmitted wirelessly to an external user interface via a flexible printed circuit board, providing continuous monitoring capabilities. The sensor is produced using a scalable and cost-effective manufacturing process called screen printing.

“Our novel hydrogel sensor technology is key to enabling the non-invasive detection of solid-state biomarkers on skin. The ionic conductive hydrogel layer that solvates the biomarkers and the electronically conductive hydrogel layer facilitates electron transport. This bilayer enables the sequential solvation, diffusion and electrochemical reaction of the biomarkers. Another highlight is the sensor’s sensitivity with biomarkers being detected precisely even in low amounts,” said Asst Prof Liu.

“This wearable sensor is the first-in-the-world that can monitor biomarkers on dry or non-sweaty skin. The sensor’s novel bilayer hydrogel electrode interacts with and detects biomarkers on our skin, allowing them to become a new class of health indicators. The stretchable design enhances comfort and accuracy as well, by adapting to our skin’s natural elasticity. This innovation can change the way we approach health and lifestyle monitoring, particularly for those living with chronic conditions requiring constant health monitoring,” said Dr Yang.

The sensor comprises an ionic electronic bilayer hydrogel that can detect solid state biomarkers from the skin. The sensor is connected to a flexible printed circuit board which transmits data wirelessly to a user interface.

Unlike traditional sensors that require biofluid samples, this sensor can continuously and non-invasively monitor SEBs directly on the skin, making it valuable for remote patient monitoring and population-wide health screening.

In clinical studies, the sensor demonstrated strong correlations between the biomarkers detected on the skin and those found in blood samples. This validates the sensor’s accuracy and reliability, suggesting it could be an alternative to blood tests for monitoring chronic diseases such as diabetes, hyperlipoproteinemia and cardiovascular conditions.

The research team is now working to enhance the sensor's working time and sensitivity and broaden its applicability by adding more solid-state analytes. They have also tapped hospitals for further clinical validation of the device, particularly for continuous glucose monitoring.

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Robot Dentist Performs World's First Procedure

Perceptive announced the completion of the first fully automated dental procedure on a human.

Perceptive, a Boston-based tech company backed by Facebook's Mark Zuckerberg’s, dad Edward Zuckerberg, trialed its technology through an in-house human test, marking a significant milestone in dental care.

The dental robot, made by Boston-based company Perceptive, has been approved by the US Food and Drugs Administration (FDA). It is guided by AI (artificial intelligence) with 3D imaging software and operates a robotic arm to perform dental tasks, Perceptive said in a press release.

The Perceptive dental robotics system integrates AI-driven 3D imaging software with a robotic arm designed to perform dental procedures, starting with restorative dentistry, with unparalleled speed and precision. The proprietary system aims to complete tasks such as crown placements in just 15 minutes, a major reduction from the current method that requires two office visits of at least one hour each.

“We’re excited to successfully complete the world's first fully automated robotic dental procedure,” said Dr. Chris Ciriello, CEO and Founder of Perceptive. “This medical breakthrough enhances precision and efficiency of dental procedures, and democratizes access to better dental care, for improved patient experience and clinical outcomes. We look forward to advancing our system and pioneering scalable, fully automated dental healthcare solutions for patients.”

Related Robot Completes Surgery in Space

Perceptive’s AI robotics system uses 3D volumetric data for diagnostics and treatment planning, enabling early and highly accurate diagnoses. The procedure begins with an optical coherence technology (OCT) scan of the patient’s tooth and mouth using Perceptive's handheld intraoral scanner. This advanced scanner captures 3D images beneath the gum line, through fluids and under the tooth surface, offering unparalleled imaging capabilities. Patients can clearly visualize their dental conditions through these detailed images, helping them better understand their need for care.

The system then uses Perceptive’s AI algorithms to analyze the 3D data and plan the procedure with efficiency and high precision. By automating these procedures, Perceptive enables dentists to diagnose and treat more patients with higher quality care in less time, reducing the need for manual labor and minimizing the chances of human error.

“The robotics system has been designed and rigorously tested to ensure that dentists can perform treatments safely, even in conditions where patient movement is prevalent,” said Edward Zuckerberg, DDS, FAGD, a pioneer in the integration of technology in the dental clinic. “This commitment to safety is core to Perceptive's dedication to providing reliable and effective dental care solutions using state-of-the art technology.”

“Perceptive’s AI-driven robotic system will transform dentistry. The patient experience will be better because of streamlining procedures and enhancing patient comfort,” said Karim Zaklama, DDS, a general dentist and multi-practice owner supported by PDS Health and member of Perceptive’s clinical advisory board.

Perceptive has raised $30 million in funding to date, with leading investors including PDS Health, Dr. Ed Zuckerberg, Innospark Ventures, KdT Ventures, Primavera Capital, Plaisance Capital, Y Combinator, and others.

About Perceptive

Perceptive is at the forefront of dental technology innovation, dedicated to developing fully automated solutions that empower dentists to provide better care to more patients. Perceptive is partnered with the Harvard School of Dental Medicine and American Dental Association's Forsyth Institute. It is backed by industry-leading investors such as Ed Zuckerberg, Innospark Ventures, KdT Ventures, Primavera Capital, Plaisance Capital, Y Combinator, and more.

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Apple Vision Pro Can Now Control Brain Implant

Brain chip Synchron operates an Apple Vision Pro simply by thinking.

Synchron, the brain-computer interface (BCI) company, announced the world’s first-ever use of Apple Vision Pro, by one of the patients implanted with the Synchron brain computer interface.

Mark, a 64-year-old man with amyotrophic lateral sclerosis (ALS), successfully used his direct thoughts to control the cursor on the Apple Vision Pro when he played Solitaire, watched Apple TV and sent text messages using the Synchron brain computer interface, hands-free. Mark is otherwise unable to use the Apple Vision Pro due to the loss of function of his upper limbs. Apple Vision Pro requires hand gestures to make item selections, Synchron said in a press release.

“This is pretty cool, I've been wanting to try this for a while now,” Mark said in reaction to using his BCI to watch a video on the Vision Pro. “It's like watching it in the theater, it really comes to life. Using this type of enhanced reality is so impactful and I can imagine it would be for others in my position or others who have lost the ability to engage in their day-to-day life. It can transport you to places you never thought you’d see or experience again.”

Related VR Surgical Training App for Apple Vision Pro

Apple Vision Pro is a revolutionary spatial computer that seamlessly blends digital content with the physical world, while allowing users to stay present and connected to others. Vision Pro creates an infinite canvas for apps that scales beyond the boundaries of a traditional display and introduces a fully three-dimensional user interface controlled by the most natural and intuitive inputs possible — a user’s eyes, hands, and voice.

Synchron's new BCI integration with Apple Vision Pro, allows for the first time – users who have lost mobility of their hands and voice to engage with the device. The BCI system is designed to be simple to use and easy to learn. This integration reflects Synchron’s commitment to patient-first innovation in neurotechnology.

“BCI is a platform to re-connect people with injury or disease back to the fast-moving consumer technology landscape. Vision Pro is a powerful system, but it relies on the use of hand gestures to exert control over the UI. We are sending control signals directly from the brain to replace the need for hand gestures,” said Tom Oxley, CEO & Founder, Synchron, “We are moving towards a new Bluetooth standard for Human Computer Interactions that don’t require touch or speech. This is a critical unmet need for millions of people with paralysis.”

The Synchron BCI is implanted in the blood vessel on the surface of the motor cortex of the brain via the jugular vein, through a minimally-invasive endovascular procedure. Once implanted, it is designed to detect and wirelessly transmit motor intent out of the brain, intended to restore the capability for severely paralyzed people to control personal devices with hands-free point-and-click.

About Synchron

Synchron is a neurotechnology company developing an endovascular brain-computer interface (BCI) designed to restore functionality in people with severe paralysis. The clinical-stage company is developing a neuroprosthesis to restore motor signaling to control digital devices and autonomy for individuals with motor impairment. Synchron is headquartered in New York City.

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India’s First VR Medical Training Lab

MediSim VR has opened India’s first VR training lab at Sri Ramachandra Institute.

MediSim VR, a leader in healthcare simulation training technology, announced the establishment of Chennai's first Center of Excellence (CoE) VR lab at Sri Ramachandra Institute of Higher Education and Research (SRIHER). This state-of-the-art facility offers access to immersive and interactive VR- training for medical students across the nation.

Since its inception, MediSim VR has benefited over 4,000 students, providing unparalleled access to immersive, hands-on medical training. The innovative VR technology employed in the lab offers realistic medical scenario simulations in a safe and controlled environment to prepare upcoming medical professionals with procedural competency, skills, and the confidence needed to care for their patients.

MediSim VR uses Virtual Reality to bridge the gap between theoretical understanding and practical application to ensure that students are well-prepared for real-world medical situations. This Center of Excellence at SRIHER redefines medical education by incorporating VR-based learning, empowering students from across the state and all over the country to perfect their skills and improve patient outcomes.

Related VR Surgical Training App for Apple Vision Pro

Dr. K. Balaji Singh, Dean at SRIHER, stated, "We're passionate about giving our students the best medical education possible. Our partnership with MediSim VR blends advanced technology and traditional teaching methods to bridge the gap between classroom theory and clinical practice. This holistic approach to medical education is our commitment to producing physicians who will make a meaningful difference in healthcare."

Dr. Adith Chinnaswami, Co-founder of MediSim VR, emphasized the importance of the new VR-based Center of Excellence for medical students. "We aim to redefine medical education and empower the next generation of healthcare professionals. The facility unlocks exciting learning opportunities not only for students from within SRIHER but also from all over the country. By incorporating VR-based learning aids into the curriculum, we are setting a new standard for medical training and education that will positively improve patient outcomes."

About Medisim VR

MediSim VR is a leading healthcare simulation company that offers patented technology designed to meet the unique needs of healthcare training worldwide. MediSim VR's AI-powered competency assessment tools and immersive virtual training environments improve the performance of nursing students, medical students, and healthcare professionals by offering unparalleled immersive experiences that redefine medical education.

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August 2024: Breakthrough in the Field of Health Monitoring

BioButton: award-winning sensor for continuous vital health monitoring with advanced AI technology.

Our Innovation of the Month August is the groundbreaking BioButton from BioIntelliSense - a real breakthrough in the field of digital health monitoring. This compact, wearable sensor is worn directly on the skin and provides continuous monitoring of vital parameters such as body temperature, heart rate, respiratory rate and even activity level. Thanks to state-of-the-art sensor technology and AI-supported analyses, the BioButton detects changes in health at an early stage and provides precise data that is invaluable not only for healthcare but also for everyday use.

The BioButton has already received great recognition in the medical industry and has won several awards, like the CES Innovation Award, which is presented for outstanding technological innovations, and the Edison Award in the "Health and Wellbeing" category. These awards underline the revolutionary importance of the BioButton in modern health monitoring.

In addition to its advanced technology, the BioButton also impresses with its user-friendliness. With a battery life of up to 90 days and ease of use, it is ideal for long-term patient monitoring, post-operative care or supporting a healthy lifestyle. The BioButton sets new standards in healthcare and shows how technology can make our lives safer and healthier.

About BioIntelliSense

BioIntelliSense revolutionizes continuous health monitoring and clinical intelligence for Remote Patient Monitoring. Its FDA-cleared BioSticker™ and BioButton® devices capture vital signs, biometrics, and symptoms with ease. The Data-as-a-Service (DaaS) platform provides clinicians with advanced analytics and detailed patient trends, enabling high-quality, remote medical care.

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These Smart Shoes Let You Walk Through a VR World

Shoes that will let you move across a virtual environment without bumping into walls.

The way that gamers navigate virtual reality environments could be completely changed by shoes that have motorized wheels. The clever kicks, which are currently being developed by the US/UK startup Freeaim, are basically tiny wearable treadmills.

While it's easy enough to replicate users' real-world head and arm movements in VR environments, walking is a bit trickier. A player can't possibly be traveling the same distance in real life—or at least not without bumping into objects—if they are walking the length of a virtual city block in a game, reports NewAtlas.

Some people claim that walking on these platforms feels more like skating or like pushing awkwardly up against the interior of a dish, according to Freeaim. Omnidirectional treadmills also need the user to be supported by a harness or wrap-around railing, and they are rather huge and costly.

On the other hand, Freeaim VR Shoes resemble more like electric roller skates.

Related Walk Faster With These Robotic Shoes

The startup claims that Freeaim's VR shoes work with all SteamVR headsets, making them a much more affordable and practical option. Every shoe resembles a sophisticated roller skate since it has two modules, each with four driven wheels. The wheels move in the opposite direction as the direction you are moving, because they are omnidirectional. This lets you remain where you are in the VR game, or within a specified two-by-two-meter area, no matter which way you go. At last, you may move around freely in a virtual reality game or other experience without worrying about hurting someone outside of it.

You can’t order Freeaim’s shoes just yet. The company has just made the device available to developers for the rather high cost of $4,999. Fortunately, a more affordable consumer version is said to be on the way. The company hopes to release a $1,000 pair for VR gamers sometime next year.

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Mind-Controlled Prosthetic Legs Enable Faster, Natural Walk

A prosthetic leg fully driven by the body’s own nervous system.

State-of-the-art prosthetic limbs can help people with amputations achieve a natural walking gait, but they don’t give the user full neural control over the limb. Instead, they rely on robotic sensors and controllers that move the limb using predefined gait algorithms.

Using a new type of surgical intervention and neuroprosthetic interface, MIT researchers, in collaboration with colleagues from Brigham and Women’s Hospital, have shown that a natural walking gait is achievable using a prosthetic leg fully driven by the body’s own nervous system. The surgical amputation procedure reconnects muscles in the residual limb, which allows patients to receive “proprioceptive” feedback about where their prosthetic limb is in space, reports Anne Trafton at MIT News.

In a study of seven patients who had this surgery, the MIT team found that they were able to walk faster, avoid obstacles, and climb stairs much more naturally than people with a traditional amputation.

“This is the first prosthetic study in history that shows a leg prosthesis under full neural modulation, where a biomimetic gait emerges. No one has been able to show this level of brain control that produces a natural gait, where the human’s nervous system is controlling the movement, not a robotic control algorithm,” says Hugh Herr, a professor of media arts and sciences, co-director of the K. Lisa Yang Center for Bionics at MIT, an associate member of MIT’s McGovern Institute for Brain Research, and the senior author of the new study.

Related These Prosthetic Hands Are Easier to Control

Patients also experienced less pain and less muscle atrophy following this surgery, which is known as the agonist-antagonist myoneural interface (AMI). So far, about 60 patients around the world have received this type of surgery, which can also be done for people with arm amputations.

Hyungeun Song, a postdoc in MIT’s Media Lab, is the lead author of the paper, which appears today in Nature Medicine.

Sensory feedback

Most limb movement is controlled by pairs of muscles that take turns stretching and contracting. During a traditional below-the-knee amputation, the interactions of these paired muscles are disrupted. This makes it very difficult for the nervous system to sense the position of a muscle and how fast it’s contracting — sensory information that is critical for the brain to decide how to move the limb.

People with this kind of amputation may have trouble controlling their prosthetic limb because they can’t accurately sense where the limb is in space. Instead, they rely on robotic controllers built into the prosthetic limb. These limbs also include sensors that can detect and adjust to slopes and obstacles.

To try to help people achieve a natural gait under full nervous system control, Herr and his colleagues began developing the AMI surgery several years ago. Instead of severing natural agonist-antagonist muscle interactions, they connect the two ends of the muscles so that they still dynamically communicate with each other within the residual limb. This surgery can be done during a primary amputation, or the muscles can be reconnected after the initial amputation as part of a revision procedure.

A natural gait

For this study, the researchers compared seven people who had the AMI surgery with seven who had traditional below-the-knee amputations. All of the subjects used the same type of bionic limb: a prosthesis with a powered ankle as well as electrodes that can sense electromyography (EMG) signals from the tibialis anterior the gastrocnemius muscles. These signals are fed into a robotic controller that helps the prosthesis calculate how much to bend the ankle, how much torque to apply, or how much power to deliver.

In all of these tasks, the people with the AMI neuroprosthetic interface were able to walk faster — at about the same rate as people without amputations — and navigate around obstacles more easily. They also showed more natural movements, such as pointing the toes of the prosthesis upward while going up stairs or stepping over an obstacle, and they were better able to coordinate the movements of their prosthetic limb and their intact limb. They were also able to push off the ground with the same amount of force as someone without an amputation.

“With the AMI cohort, we saw natural biomimetic behaviors emerge,” Herr says. “The cohort that didn’t have the AMI, they were able to walk, but the prosthetic movements weren’t natural, and their movements were generally slower.”

These natural behaviors emerged even though the amount of sensory feedback provided by the AMI was less than 20 percent of what would normally be received in people without an amputation.

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Collaboration Brings VR Experience to Care Homes

Rendever announced the deployment of its virtual reality platform with Lenovo.

Rendever, the Boston-based company pioneering the future of aging through virtual reality (VR), announces the deployment of its virtual reality platform with Lenovo to Carolina Caring patients. The rollout allows clinicians and caregivers to bring expansive, once-in-a-lifetime VR experiences to older patients whose worlds have become limited.

Over the last year, Rendever and Lenovo combined their products into a joint solution that senior living providers can easily adopt to improve the quality of life for older adults through positive shared experiences. Rendever’s award-winning virtual reality solution delivered on Lenovo’s ThinkReality VRX headset provides an all-in-one standalone solution that meets the evolving needs of enterprises with modern virtual reality with six degrees of freedom, full color, and high-resolution experiences. Rendever is deployed in over 700 communities nationwide and looks to further expand with the addition of Carolina Caring in collaboration with Lenovo, Rendever said in a press release.

“For us, it’s all about delivering magical moments that ignite new relationships and conversations that ultimately lead to healthier, happier lives. It’s exciting to see the rising tide of VR hardware providers joining our mission to enhance the lives of older adults. Partnering with Lenovo to service Carolina Caring has been a delight, and we’re thrilled for the future,” said Rendever CEO and Co-Founder Kyle Rand.

“It’s been incredible to see our patients interact with each other and virtually explore parts of the world they’ve never been able to before with this holistic approach and see how it positively impacts their wellbeing. For example, we’ve seen anxious patients with tremors become at ease during a VR session. Our caregivers and clinicians can easily integrate the technology into our programming and offer these special moments to our patients,” said Kelly Tate, VP of Community Relations at Carolina Caring.

Related VR Surgical Training App for Apple Vision Pro

“VR experiences can have the power to inspire, inform and enhance well-being because they are immersive and even breathtakingly vivid,” said Jason McGuigan, Head of Commercial Virtual Reality, Lenovo. “Transforming the patient experience with a solution like this is a big part of Lenovo’s mission to bring smarter technology for all.”

About Rendever

Rendever is overcoming social isolation through the power of virtual reality and shared experiences. From senior living communities to hospitals, the platform is being used to reduce depression and loneliness by fostering personal connections amongst populations where life has become limited. Participants in group sessions can check off bucket list items together, revisit meaningful places and share stories, stay engaged with family members, and more. Rendever is being used by high-profile senior living operators including Revera, Benchmark, and SRG, healthcare systems such as UCHealth and Cleveland Clinic, has research funded by the NIH and NIA, and has commercial partnerships with major organizations like AARP and Verizon. Rendever is a three-time Inc. 5000 honoree, two-time TIME Best Invention winner, and a TIME100 Most Influential Company.

About Carolina Caring

Carolina Caring, founded in 1979, is an independent, community-based, nonprofit healthcare provider. It specializes in programs that offer relief from chronic conditions, serious illnesses, and the challenges they bring, including palliative medicine and hospice care for all ages, primary care and grief counseling. Carolina Caring serves 12 counties across western North Carolina and the Charlotte Region.

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GE HealthCare and MediView Launch AR Radiology Suite

MediView’s augmented reality–based interventional radiology suite.

GE HealthCare (Nasdaq: GEHC), a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, and MediView XR Inc., a leading clinical augmented reality med-tech company, announced the successful first installation and clinical cases using the OmnifyXR Interventional Suiteat North Star Vascular and Interventional in Minneapolis, Minnesota. This innovative augmented reality-based interventional radiology suite combines a holographic heads-up display streaming live medical imaging, 3D anatomy model visualization and advanced imaging technologies, while enabling the opportunity for remote collaboration to help advance the delivery of precision care across a variety of interventional procedures.

Related Mojo Vision Unveils Augmented Reality Contact Lens Prototype

Image-guided therapy is a fast-evolving space that leverages advanced imaging and visualization solutions to make it possible to treat many conditions, from cancer care to cardiovascular disease and more, with little to no surgical incisions. However, while performing these different interventional procedures, practitioners face many challenges - from positioning restrictions that obscure visual interface and display access, to time consuming workspace adjustments, GE HealthCare said in a press release.

To address these challenges, OmnifyXR was designed to fit seamlessly into existing interventional suites and leverages augmented reality to support workflow efficiency and ergonomics, improved visualization, and collaborative care.

OmnifyXR leverages augmented reality innovation and is designed to support clinicians in the following ways:

Workflow efficiency and ergonomics: Heads-up display (HUD) headset holographically displays multiple imaging video streams in a customizable way to create opportunities for improved ergonomics regardless of working position. Clinicians can simultaneously display up to four video streams (such as Live Fluoroscopy, Reference Image, Advantage Workstation Image, Ultrasound and Hemodynamics); customize the size, angle and orientation to meet workflow needs; and utilize voice commands for hands-free interaction with the application.

Improved visualization of anatomy with 3D Assist: Designed to augment visualization and help in the assessment of complex anatomies, clinicians can interact with a holographic 3D  model of the patient’s anatomy to support intraprocedural planning.

Collaborative care: To allow for remote collaboration, consultation, training, proctoring and support, users can provide first-person view of their holographic experience through any internet-connected device to allow for collaborative care from any location.

In the world’s first clinical use of OmnifyXR, Professor of Radiology and founder of North Star Vascular and Interventional Dr. Jafar Golzarian performed two separate clinical procedures – the embolization of a genicular artery and the embolization of a prostate artery.

“The heads-up display and augmented reality capabilities of OmnifyXR, especially the 3D anatomical view offered by the hologram scan, are game-changing and allow for new perspectives into treatment we haven’t seen before,” said Dr. Jafar Golzarian of North Star Vascular and Interventional. “I’m excited to be on the team performing these first cases and look forward to seeing how this may help improve clinical and operational outcomes for both patients and clinicians.”

“OmnifyXR will change the way I approach my cases,” shared Dr. Amin Astani of North Star Vascular and Interventional. “With GE HealthCare’s Allia platform, I can create a highly detailed 3D generated model in a matter of minutes without having to remove my sterile gloves to help maintain sterility during the procedure. Using MediView’s OmnifyXR, I can virtually place this 3D model anywhere in the room - allowing me to walk around it and evaluate it from different angles and perspectives in order to make more informed decisions about the way I approach and navigate my procedures.”

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Zepp Health Integrates ChatGPT into Its Smartwatches

Zepp Health, a global leader in smart wearables and health technology.

Zepp Health Corporation, a global leader in smart wearables and health technology, unveiled Zepp OS 4, a ground-breaking advancement in wearable technology. This latest iteration integrates OpenAI’s-GPT-4o most advanced system, producing safer and more useful responses and enhancing the functionality of Amazfit smartwatches to serve as comprehensive wellness companions.

With a suite of innovative features and enhancements, Zepp OS 4 is set to redefine user experience, offering unparalleled convenience, accuracy, and engagement. Available for download now for the Amazfit Balance and Amazfit Active, with support for the Amazfit T-Rex Ultra, Falcon and Cheetah series coming later in 2024, key highlights include:

Enhanced Zepp Flow Integration

Zepp OS 4 introduces an upgraded Zepp Flow™, leveraging OpenAI’s-GPT-4o technology to facilitate natural language interactions more intelligently. Users can seamlessly control their devices through voice commands, without the need for specific keywords or physical touch. This intuitive interface sets a new standard for smartwatch usability, empowering users to effortlessly manage settings, reply to instant messages from Android apps like WhatsApp (iOS will be supported in the near future), and initiate Bluetooth phone calls - all by simply using their voice, the company said in a press release.

Expanded Language and Voice Capabilities

With Zepp OS 4, Zepp Flow can reply back to the user in spoken English and German - a step up from written replies on the display - with French, Italian, Spanish, Japanese, Korean, and Portuguese voice replies coming in late July. This enhancement ensures a personalized user experience across multiple linguistic preferences, further cementing Amazfit smartwatches as global companions for health and productivity.

Enhanced Bluetooth and Messaging Integration

Incorporating advanced Bluetooth capabilities, Zepp OS 4 enables seamless integration with a wider array of peripherals. Users can now utilize their Amazfit devices to control compatible devices such as Sonos speakers, Garmin cycling meters, and even GoPro and DJI action cameras, enhancing their daily activities and fitness routines.

Related Smartwatch Lets You See Blood Flow Inside Your Body

Innovative Mini Apps and Fitness Solutions

Zepp OS 4 also unveils an expansive ecosystem of mini apps tailored for health and fitness enthusiasts. The update introduces a range of tools from sports positioning aids to specialized fitness tests. A standout addition is the Workout Extension type of mini-app, exclusively available in the app store, catering specifically to sports enthusiasts. Compatible with Zepp OS 3.5 devices like the Cheetah series, Falcon, and T-Rex Ultra, this innovative feature personalizes the user's watch interface during workouts. By empowering users to personalize their devices according to individual wellness goals, Amazfit smartwatches become indispensable tools for active lifestyles.

Driving User Engagement and Innovation

Since its inception, Zepp Health has shipped over 200 million units globally, establishing itself as a trusted brand in wearable technology. The Zepp App boasts over 300 downloadable mini apps, downloaded over 15 million times, and offers more than 5,700 watch faces, downloaded over 72 million times, highlighting the extensive customization and user engagement within the ecosystem.

Commitment to Personalized Wellness Solutions

By integrating AI deeply into Zepp OS 4 Zepp Health continues to pioneer personalized wellness solutions. From AI-driven sleep guidance in Zepp Aura to real-time fitness coaching in Zepp Coach, the seamless integration of AI across its ecosystem underscores Zepp Health's commitment to enhancing user well-being through cutting-edge technology.

About Zepp Health Corporation

Zepp Health is a global smart wearable and health technology leader. Its leading consumer brands, include Amazfit, Zepp Clarity, and Zepp Aura.

Leveraging its proprietary Zepp Digital Health Management Platform, Zepp Health delivers actionable insights and guidance to users worldwide. With a presence in over 90 countries and a robust ecosystem of products and services, Zepp Health is at the forefront of advancing wearable intelligence and digital health technology.

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New Partnership Launches Patient Monitoring Smartwatch

The latest innovation in personal emergency alarms.

KORE, a global leader in IoT Solutions, and mCare Digital, a leader in assistive technology, announced the launch of the mCareWatch 241, the latest innovation in personal emergency alarms. By providing the connectivity and provisioning platform needed to seamlessly connect the wearable devices, KORE enables mCare to virtually monitor patients in their homes or healthcare facilities.

Recently awarded the Best Innovative Assistive Technology product at the Asia Pacific Eldercare Awards in Singapore, the mCareWatch 241 showcases mCare Digital's commitment to innovation and customer satisfaction.

Richard Tuke, vice president of sales for KORE EAP, is delighted to help push the needle forward when it comes to personal emergency technology. "Congratulations to mCare on their award-winning innovative health watch. Powered by IoT, this cutting-edge technology is truly enhancing lives and setting new standards in healthcare," said Tuke. "Here's to continued success and transforming health monitoring for individuals everywhere."

Designed to offer the dignity of independence coupled with the security of immediate assistance, the mCareWatch 241 provides a new level of freedom and connectivity for users and caregivers alike. Each feature, from its lightweight design to extended battery life, was crafted to ensure all users can navigate their daily lives with confidence and ease.

Related Dexcom G7 Now Connects Directly to Apple Watch

Peter Apostolopoulos, co-founder of mCare Digital, is dedicated to enabling independence for individuals who need it most, like seniors and those living with disabilities. "The mCareWatch 241 represents our dedication to listening and responding to the needs of our customers. We are thrilled to offer a product that not only meets but exceeds the expectations of those we serve," said Apostolopoulos. "This new model reflects our commitment to providing innovative, reliable, and user-friendly assistive technology."

About KORE

KORE is a pioneer, leader, and trusted advisor delivering mission critical IoT solutions and services. We empower organizations of all sizes to improve operational and business results by simplifying the complexity of IoT. Our deep IoT knowledge and experience, global reach, purpose-built solutions, and deployment agility accelerate and materially impact our customers' business outcomes.

About mCare Digital

mCare Digital Pty Ltd is an Australian software company focused on using the latest technology to provide human-centred solutions for caring, wellbeing and independent living. In addition to smart wearable mCareWatch devices such as watches and the mCareMate Safety Alarm, it has developed the ConnectiveCare software platform to provide organizations with functionality, information, and insights to support better caring and more advanced healthcare. The easy-to-use proprietary platform can be adapted to suit a wide range of needs including linking wearable, biometric and other healthcare devices via Bluetooth 2.0 and 4G connectivity.

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Abbott Receives FDA Clearance for Two CGMs

Abbott received FDA clearances for two new over-the-counter CGM systems.

Abbott announced U.S. Food and Drug Administration (FDA) clearance for two new over-the-counter continuous glucose monitoring (CGM) systems – Lingo and Libre Rio, which are based on Abbott's world-leading FreeStyle Libre continuous glucose monitoring technology, now used by about 6 million people globally. The newly cleared systems have been intentionally designed to meet different needs – Lingo for consumers who want to better understand and improve their health and wellness, and Libre Rio for adults with Type 2 diabetes who do not use insulin and typically manage their diabetes through lifestyle modifications.

Related Abbott Wins FDA Breakthrough Device Designation

"There is no one-size-fits all approach for glucose monitoring, which is why we've designed different products for different people – all based on the same world-leading biowearable technology," said Lisa Earnhardt, executive vice president and group president of Abbott's medical devices business. "People living with diabetes need certain features like tracking medications or sharing data with a healthcare provider. People without diabetes need different features to manage their metabolic health, including personalized coaching to promote actionable lifestyle changes."

Lingo

Abbott's consumer biowearable, Lingo, is designed for consumers 18 years and older who are looking to improve their overall health and wellness. Lingo will track glucose and provide personalized insights and customized coaching to help people create healthy habits, retrain their metabolism and improve their overall well-being, Abbott said in a press release.

According to a University of North Carolina study, only 12 percent of Americans are metabolically healthy based on five key indicators of metabolic health, including glucose levels, indicating that most of the U.S. population has room to improve their metabolism. In addition, in a recent online consumer survey conducted by The Harris Poll on behalf of Abbott, 82 percent of Americans say they would change their habits if a biowearable provided actionable, personalized coaching to help them manage their health.

The Lingo system combines a biosensor that is worn on the upper arm for 14 days5 and continuously streams glucose data to a coaching application on a smart phone – translating the body's language and giving insights on the person's reaction to food, exercise and life's daily stressors.  

"Continuous glucose monitors are a tool I recommend to my patients to raise their overall awareness of factors that affect their glucose and are an invaluable holistic wellness solution," said Fred St. Goar, M.D., cardiologist and medical director of El Camino Health Heart and Vascular Institute. "Research has shown that overall lower glucose exposure in the general population is associated with reduced long-term risk to developing cardiovascular disease, diabetes, Alzheimer's and certain cancers. Making continuous glucose monitors widely available will undoubtedly have a dramatic effect on the overall health and well-being of the broader population."

Libre Rio

Libre Rio will be Abbott's first over-the-counter CGM system for people with diabetes in the U.S. It is designed for people ages 18 and older with Type 2 diabetes who do not use insulin and typically manage their diabetes through lifestyle modifications. Libre Rio is the first over-the-counter CGM system with a measurement range of 40-400 mg/dL, allowing for measurement of extremely low or high glucose events.

Diabetes is among the top public health challenges in the U.S., with approximately 38.4 million people living with the condition6. FreeStyle Libre systems have been available over-the-counter in more than 50 countries over the last decade; however, in the U.S., they have only been available through prescription.

Libre Rio will join Abbott's overall Libre portfolio of CGM systems, now used by about 6 million people across more than 60 countries. The Libre portfolio in the U.S. consists of the FreeStyle Libre 2 and FreeStyle Libre 3 systems for people with all types of diabetes – Type 1, Type 2 and gestational. FreeStyle Libre systems require a prescription and have wide reimbursement by most major insurers in the U.S. Libre Rio may make it easier for Americans with diabetes to try a CGM and begin to see progress toward their health goals, empowering them with information to discuss with their healthcare provider at their next visit.

Clinical and real-world data from the millions of people that use FreeStyle Libre systems show that the technology helps people improve their glucose control, lower their HbA1c, decrease diabetes-related hospital admissions, and improve their quality of life7,8. Libre systems consist of a biosensor placed on the back of the arm for up to 15 days, and a reader or a compatible smartphone app9, which displays glucose measurements.

Abbott continues to invest in its world-leading innovation for people with diabetes, including expanding manufacturing capacity and developing a first-of-its-kind sensor that is designed to measure both glucose and ketone in the same sensor.

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Aktiia Receives CE Approval for BP Monitor

Aktiia announced it has received CE mark for its next-generation optical technology.

Aktiia, the Swiss startup revolutionizing Blood Pressure (BP) monitoring and management, announced it has received regulatory approval (CE mark) for its next-generation optical technology that does not require calibration with a traditional cuff. The CE mark allows market access to potentially over 40 countries. The underlying groundbreaking calibration-free technology, known as CALFREE™, uses input from optical sensors commonly found in either smartwatches or the cameras of commercial smartphones. This is a crucial first step towards integrating Aktiia's CALFREE technology into various third-party devices.

Since its inception in 2018, Aktiia has been an innovative pioneer of blood pressure technology, known for its scientific rigor, visionary team, and initial breakthrough product – the first continuous BP monitoring device worn on the wrist, which currently requires monthly calibration. Today's announcement represents a significant advancement in BP data collection and hypertension management, enabling the development of optical systems that do not require any calibration while meeting the stringent BP performance thresholds for regulatory approval, Aktiia said in a press release.
"The ability to monitor blood pressure without using a cuff is a game-changer. This achievement has the potential to greatly improve hypertension care, from better patient motivation to more efficient medication regimens," said Adrian James, former President of Omada Health.

Aktiia's blood pressure dataset is growing exponentially, with over 10 billion signals from more than 70,000 users worldwide, creating countless opportunities for discoveries that advance our collective understanding of blood pressure and provide predictive insights on a global scale. This extensive dataset has enabled Aktiia to create unprecedented Foundation Models of blood pressure, previously unattainable without the size and richness of this extensive dataset.

Related Binah.ai Unveils Contactless Blood Pressure Monitoring System

Transforming Wearables and Smartphones into Medical-Grade Devices

Approval of the CALFREE technology sets the stage for Aktiia to transform BP monitoring and management by enabling the integration of a medical-grade blood pressure system into a wide range of consumer devices (smartwatches, smartbands, and smartphone cameras), dramatically changing the ease and convenience of collecting data on one of the most impactful vital signs – blood pressure.

"This regulatory approval of Aktiia's CALFREE technology is the realization of a lifetime of work and a crucial step towards achieving our ultimate dream – to improve BP management and reduce the impact of hypertension on global health," said Dr. Josep Sola, CTO and Co-founder of Aktiia.

Addressing a Global Health Crisis

Hypertension, often referred to as a "silent killer," is the leading cause of cardiovascular diseases worldwide. The World Health Organization (WHO) reports that the number of adults with hypertension has doubled from 650 million in 1990 to 1.3 billion in 2019, with projections reaching 1.5 billion by 2025. The current methods of blood pressure monitoring, still reliant on 19th Century technology, involve cumbersome and often inaccurate cuff-based devices, and are inadequate for the growing need for effective hypertension management in the modern age.

About Aktiia

Founded in Switzerland in May 2018, Aktiia was created out of a passion to develop the best products for diagnosing and treating hypertension. Founders Drs. Mattia Bertschi (CEO) and Josep Solà (CTO) spent 15 years at the prestigious Swiss research institute CSEM, deciphering the language of the heart to deepen our understanding of blood pressure. Today, Aktiia's diverse team of over 50 extraordinary individuals is transforming years of innovative research into a global healthcare solution, offering the most complete and intuitive blood pressure monitoring and management tools on the market.

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December 2025: Miniaturized Temperature Sensing Accuracy

AS6223 – Miniaturized temperature sensing accuracy for next-generation wearables.
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November 2025: Transforming Cancer Care with Wearables

Wearable implant delivering continuous, personalized cancer therapy for everyday life.
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October 2025: The New Era of Meta Smart Glasses

Meta Smart Glasses 2025: Sleek, AI-powered eyewear for hands-free capture and connection.
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September 2025: Innovation in Oxygen Monitoring

OxiWear - Innovation in wearable health, protecting you from silent hypoxia every day.
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August 2025: Ultra-Thin Battery Revolution in Wearables

NGK's 0.45mm EnerCera Battery: Non-Swelling, Non-Flammable Power for Wearables
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July 2025: Mudra Link - Neural Gesture Control Wristband

Touchless neural wristband for seamless gesture control across devices and platforms.
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June 2025: Biobeat’s Next-Generation Wearable Solution

AI-powered wearable for continuous, cuffless vital sign monitoring in clinical and home settings.
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May 2025: Breakthrough in Continuous Glucose Monitoring

Needle-free biosensor patch for real-time glucose monitoring and metabolic health insights.
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April 2025: Robeauté’s Brain Microrobot

Robeauté's microrobot enables precise, minimally invasive brain intervention with cutting-edge tech.
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March 2025: The Future of Cognitive Health

G.Brain boosts focus and brain health with AI-powered neurotechnology.
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February 2025: Revolutionizing Women's Health

Nettle™ by Samphire Neuroscience: A non-invasive, drug-free solution for women's health.
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January 2025: The Future of Heated Apparel

Revolutionizing heated clothing with sensor-driven, real-time temperature control.
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December 2024: Remote Health with Smart Patches

Wearable tech enables non-invasive, continuous health monitoring, transforming patient care.
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November 2024: Bearmind Launches Brain Health Wearable

Bearmind’s helmet sensor tracks head impacts in real time, advancing safety in contact sports.
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October 2024: Ambiq Empowers Digital Health with Edge AI

Ambiq’s low-power chips enable personal AI on-device for digital health and remote monitoring.
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September 2024: The Revolutionary .lumen Glasses

Empowering the visually impaired with smart, award-winning technology for greater independence.
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August 2024: Breakthrough in the Field of Health Monitoring

BioButton: award-winning sensor for continuous vital health monitoring with advanced AI technology.
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July 2024: Innovation in the Fight Against Voice Disorders

Speaking without vocal cords, thanks to a new AI-assisted wearable device.
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June 2024: World's Most Accurate Hydration Sensor

To prevent cramps and collapses, the company FLOWBIO has launched its hydration sensor S1.
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May 2024: Innovation in the Fight Against Hearing Loss

Neosensory's Clarify - A breakthrough solution to improve hearing.
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