California-based hearing aid maker Ceretone has launched Core One Pro--a tiny, nearly invisible hearing.

Building on Ceretone's original Core One model, the Core One Pro is the result of more than two years of intensive research and development.  With the help of thousands of actual customers' insightful comments, our most recent version has produced a gadget that is both notably more powerful and compact, offering improved comfort and remarkably clearer, more natural sound quality.

The most noteworthy aspect of the Core One Pro is its invisible capabilities.  It is categorized as an Invisible-in-Canal (IIC) gadget since it is made to fit entirely inside the ear canal, making it nearly invisible to the naked eye.  It is one of the lightest hearing aids available, weighing only 0.035 oz, or about the weight of a paperclip, reports New Atlas.

"After wearing it for a few hours, I completely forgot it was there—and no whistling at all," reports one early user, echoing feedback from hundreds of customers. This exceptional comfort comes from analyzing over 10,000 ear canal samples, paired with multiple sizes of soft, ergonomic open eartips.

The Audio 16 chipset, which is derived from Intricon, a U.S. business with forty years of experience in micromedical technology, is what technically distinguishes the Core One Pro.  This processor, which was first created for prescription hearing aids, has been modified for over-the-counter usage, giving regular people access to professional-level performance at a cost they can afford.

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Through this collaboration, Ceretone's state-of-the-art technology and Intricon's vast knowledge of hearing technology are combined to create a potent synergy that produces incredibly realistic, crystal-clear sound reproduction and improved audio clarity.  As a result, a wider audience can now get professional-grade performance that was previously only possible with pricey prescription devices.

Pricing and availability

At $329 during the launch month and $389 thereafter, the Core One Pro costs roughly one-tenth of traditional prescription hearing aids, which typically range from $4,000 to $8,000 per pair.

The Core One Pro is now available for purchase at the company’s website and will be soon available on Amazon.

Hong Kong-based startup Dnsys has developed a knee exoskeleton that boosts leg strength by 50%. The Z1 knee exoskeleton also reduces knee pressure by 200%. The company was founded four years ago by robotics experts who previously worked for companies like Segway, DJI and Xiaomi.

Dnsys Z1 delivers continuous power to the wearer’s whole leg, helping them to climb higher, walk farther, and push past their limits, according to the Kickstarter campaign.

Dnsys’ independently developed knee motor delivers up to 900W of power. Its unique design transmits force simultaneously to the thigh and calf backs, generating lifting and pushing support for double output. This innovation provides strong assistance and significantly improves movement stability.

50% Boost to the Leg

Dnsys Z1 delivers up to 50% intelligent leg assistance, tackling slopes, challenges, and heavy loads, reducing burden by up to 77 lbs. It cuts muscle fatigue for farther walks, higher climbs, and effortless movement. Hikes: +15.5 miles. Climbs: +9.3 miles vertical.

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200% Body Weight Pressure Reduction

We rely on our knees every day, yet often overlook how much stress they endure. While skiing, our knees can bear up to 700% of our body weight; hiking puts them under 500%, and even walking downstairs adds 300%. These repeated impacts silently wear down our knee health over time.

The Z1 uses AI-powered motors to evenly deliver force to the backs of the thighs and calves, providing intelligent cushioning that disperses and absorbs impact on the knees. It detects movement and load in real time, applying lifting force whenever the knees need support.

Two 1.5-lb (680-g) hinged exoskeletons that fit in a backpack and can be erected on each leg in a claimed 15 seconds make up the arrangement.  Then, using padded supports, a 450-watt motor in each unit applies force to the thigh and the backs of the calf, pushing out against the calf and simultaneously raising the thigh forward.

When leg movements are detected by onboard torque, position, and force sensors, the motors are activated in as little as 0.01 seconds.  As the user's movement patterns are learned by AI algorithms operating on a dual-core 240-MHz CPU (one per unit), the electrical aid can be applied more fluidly and organically.

Indeed, it has been reported that the AI can identify motions and change the help modes for tasks including walking, running, cycling, leaping, squatting, sitting, and standing.

Dnysys is offering the Z1 in three models. The mid-range aluminum/carbon fiber Dual Joint, which is described in this article, could be yours for a pledge of US$899 if it reaches production. The planned retail price is $1,499.

Meta researchers have created a wristband that can move a cursor, transform hand movements into orders to connect with a computer, and even turn scribbling in the air into text. People with limited movement or weak muscles may find it much easier to use today's personal electronics, and it may even open up new possibilities for easy device operation.

The Reality Labs team detailed their sEMG-RD (surface electromyography research device) in a paper published this week in Nature. It uses sensors to convert electrical motor nerve signals that pass through the wrist to the hand into digital commands that can be used to control a device that is connected, reports New Atlas.

Essentially, the bracelet’s sensors can track nerve signals that run through the wrist, translating them into commands for a connected device. This includes allowing users to navigate an interface, control a cursor, type, and much more. The team says that this technology has much more to offer, and that further development will yield more concise control and additional applications.

Years ago, Meta started working on this.  The company prototyped an electromyography-based gesture control device in 2021 with the help of a team led by Thomas Reardon, who became director of neuromotor interfaces at Reality Labs in 2019.  In order to improve interactions in augmented reality experiences, Meta was eager to create this technology at the time. At first, their goal was to make basic interactions possible, such as simulating a single mouse click.  The study described in this paper was also led by Reardon.

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In addition to controlling a one-directional onscreen cursor (such as a laser pointer), you can use thumb swipes, thumb taps, and finger pinches to move through an interface and pick items.  Even better, you can mimic handwriting and type text at a respectable 20.9 words per minute.  Given that the average person types 36 words per minute on a phone keyboard, that last one is particularly clever.

Furthermore, although it can be adjusted for further customization, this system does not require calibration for each user before use.  Regardless of who was using the wearable, the team devised a way to collect training data from study participants at scale and then process it through a neural network to precisely convert raw signals into commands.

According to the team, this technology might be further refined to directly detect the intended force of a gesture and be used in more complex joystick and camera controls.  Additionally, it might lessen the already minimal physical effort needed to use phones and other electronic gadgets.

Next year, Snap will introduce its first-ever smart glasses to the general public, intensifying battle with larger rival Meta and launching a new product in the wearable technology space.

The social network business announced on Tuesday that the augmented reality smart glasses, known as Specs, will be lightweight, reports Reuters.

“We believe the time is right for a revolution in computing that naturally integrates our digital experience with the physical world. That’s why we’ve spent 11 years and more than $3 billion to invent a new type of computer for augmented reality, designed to enhance the physical world with digital experiences. We call them Specs, an ultra-powerful wearable computer integrated into a lightweight pair of glasses with see-thru lenses, and they’re coming next year,” Snap said.

Long renowned for its colorful filters and messaging app, Snapchat has been focusing more on augmented reality (AR), which allows users to superimpose digital effects on images or videos of their actual environment taken with a camera or lens.

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In an unpredictable digital ad market brought on by shifting U.S. trade policy, Snap can diversify its revenue streams and access new, profitable markets by incorporating technology into wearable items.

Only developers had access to the company's fifth generation of Spectacles spectacles, which were introduced in September.
The company has invested more than $3 billion over 11 years developing its augmented reality glasses, Snap co-founder and CEO Evan Spiegel said at the Augmented World Expo 2025 on Tuesday.

"Before Snapchat had chat, we were building glasses."

In an effort to draw in more customers, Meta keeps incorporating AI capabilities into its glasses.

In order to improve Lens Studio—an application that allows developers to design, animate, and publish AR lenses for the Snapchat camera—and Specs, Snap announced a partnership with Niantic Spatial, a platform that combines augmented reality and geolocation technologies.

Canadian fitness technology company FORM launched one of its highly anticipated second-generation augmented reality swim goggles, FORM Smart Swim 2.

“We believe passionately in empowering athletes through real-time feedback via augmented reality, and this next generation of our smart swim goggles exemplifies our relentless pursuit of excellence in design and performance", said Dan Eisenhardt, FORM CEO.

As the creator and dominant player in the smart swim goggles space, FORM has consistently delivered cutting-edge solutions that cater to both triathletes and swimmers of all abilities, the company said in a press release.

Building on the award-winning success of the Smart Swim 1, FORM Smart Swim 2 leverages patented Waveguide optics technology and an array of onboard sensors to deliver real-time metrics, guided workouts and unparalleled real-time swim coaching.

The excitement surrounding the FORM Smart Swim 2 stems from its innovative new features:

• Integrated Heart Rate Monitoring: A groundbreaking temple-based integrated heart rate sensor provides a reliable and accurate way to monitor heart rate in the water, making real-time heart rate-based zone training accessible to all swimmers.
• SwimStraight: Incorporating a first-of-its-kind digital compass, SwimStraight enhances open-water swim confidence by enabling swimmers to follow in-goggle directional heading. This reduces course deviations and improves overall swim efficiency.

FORM Smart Swim 2 goggles, and all included features, have been granted race approval by World Triathlon, USA Triathlon, the Professional Triathletes Organization (PTO), and supertri.

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Over the past four years, the FORM team has refined its industrial design approach, applying extensive learnings and hydrodynamic research to further optimize performance. Smart Swim 2 boasts the following refreshed design features:

15% Size Reduction: The Smart Swim 2 goggles’ tech pack—containing the accelerometer, gyroscope, magnetometer, and barometer – is now 15% smaller, by volume, than its predecessor, delivering a sleeker, more hydrodynamic design.

Enhanced Fit & Comfort: With comfort being imperative, new proprietary eye seals now fit the contours of a wider variety of facial structures. Extended temples provide a new connection point for the goggles’ strap for enhanced stabilization, while the inclusion of five arched nose bridges ensures a more comfortable, secure, optimal fit.

FORM has also rolled out updates to its HeadCoach digital coaching technology. First unveiled in October 2023, HeadCoach gives swimmers real-time in-goggle access to technique awareness, focused skill development (HeadCoach Skills), and in-app education and analysis.

The latest HeadCoach update, using the goggles' onboard sensors, constantly evaluates performance and technique data to determine areas of improvement. HeadCoach’s machine-learning algorithms will automatically generate a variety of personalized workouts designed to make you a better swimmer. Additionally, HeadCoach Skills prompts will now appear automatically in Free Swim mode and can be manually built into custom workouts enhancing training impact and skill acquisition.

“Unveiling our second-generation product builds upon our legacy of delivering the best, most cutting-edge solutions for swimmers of all abilities”, said Eisenhardt.
Eisenhardt continued, “Smart Swim 2’s built-in heart rate sensor eliminates the inconvenience of purchasing, attaching, and pairing a separate device and displays accurate continuous real-time heart rate for optimal training and racing.” For open water swimmers, “SwimStraight is truly transformative, particularly for triathletes, offering an intelligent guide to keep your swim path straight and true, saving energy, time and improving focus,” Eisenhardt commented.

“In an Olympic year, and as a data-driven athlete, I must have access to the best technology available to me. The FORM Smart Swim 2 gives me that technology and insights that enable me to train and perform at my best”, said Kristian Blummenfelt, defending Olympic and World Champion triathlete.

FORM Smart Swim 2 is now available for purchase for $249.00/£229.00/€249.00 from the company’s website.

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At 0.45mm thick and weighing less than 1g, NGK Insulators' EnerCera battery is redefining what's possible in wearable device design. These ultra-thin, compact lithium-ion rechargeable batteries are specifically engineered for wearable applications across health monitoring, athletic performance tracking, beauty devices, and consumer wearables - delivering the ideal balance of power, safety, and user comfort that eliminates the traditional trade-offs between performance and wearability.

From a safety perspective, they are designed to prevent overheating, eliminate fire risk, and avoid ignition under normal and stressed operating conditions. This non-flammable, thermally stable performance is particularly vital for wearable devices that maintain close contact with users' skin.

Critically for wearable design, the batteries do not swell, eliminating risks of device malfunction or user harm. The batteries deliver exceptional reliability through minimal self-discharge rates for extended power retention, are highly resistant to float conditions, and remain rechargeable even in over-discharge conditions.

The semi-solid-state batteries feature proprietary crystal-oriented ceramic electrodes, distinguishing them from conventional Li-ion batteries. By utilizing active materials sintered as ceramics with minimal liquid electrolyte, the technology enhances both safety and reliability by eliminating organic binders.‍

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Key Applications Driving Adoption

Sports: Smart Insoles

EnerCera's ultra-thin 0.45mm profile integrates seamlessly into smart insoles, enabling undetectable gait analysis and performance tracking. The battery withstands rigorous bending and compression stresses from athletic activity while maintaining reliable power delivery.

Beyond sports applications, EnerCera-powered smart insoles support healthcare monitoring for elderly users and early detection of neurological conditions like Parkinson's disease through continuous gait pattern analysis.

The battery withstands rigorous bending and compression stresses from athletic activity, with the EnerCera Pouch demonstrating over 10,000 combined longitudinal and lateral bend cycles at just 0.45mm thickness, while maintaining reliable power delivery.

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Medical: Wearable Patch

EnerCera’s ultra-thin 0.45mm profile enables comfortable medical monitoring patches that patients can wear continuously without compromising comfort. This thin and flexible design allows the patch to conform closely to the skin, ensuring stable sensor contact and reliable data collection over extended periods of use.

Incontinuous glucose monitoring (CGM) applications, EnerCera’s long operational life supports long-term device usage, meeting eco-friendly goals. This enables patients to use a single device for prolonged monitoring periods, minimizing the frequency of replacements - particularly of batteries - and contributing to a substantial reduction in electronic waste.

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Beauty: Wearable Devices

EnerCera delivers safe, reliable power for beauty devices used in sensitive areas, including around the eyes requiring maximum safety standard. The battery's non-flammable, thermally stable design eliminates heating risks during close skin contact, making it ideal for eye masks and facial beauty devices.

The ultra-thin profile enables sleek, comfortable beauty wearables that users can incorporate into daily routines without bulk or discomfort. EnerCera's lightweight design and swelling resistance ensure beauty devices maintain their elegant form factor while delivering consistent performance for skincare treatments and cosmetic applications.

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NGK collaborates as a partner with various companies to develop superior wearable devices enabled by EnerCera technology.

About NGK Insulators' EnerCera Technology

• ‍Ultra-Thin Design: At 0.45mm thickness and weighing less than 1g, EnerCera batteries enable previously impossible wearable device designs while maintaining high energy density.‍
• Advanced Safety: Crystal-oriented ceramic electrodes with minimal liquid electrolyte and no organic binders provide exceptional thermal stability, making them suitable for direct skin contact applications.‍
• Reliability: Reliable performance with low self-discharge, low degradation during over-discharge, and no swelling—ensuring consistent power and perfect fit throughout the battery's lifespan.
• More: EnerCera Product Information and Technical Specifications

A new bionic knee created by MIT researchers can assist individuals who have had above-the-knee amputations move more quickly, climb stairs, and dodge obstacles more readily than they could with a conventional prosthesis.

The new system integrates directly with the user's bone and muscle tissue, unlike prostheses where the residual limb rests inside a socket. This allows for more stability and greatly increases the user's control over the prosthesis's movement, Anne Trafton reports MIT News.

Compared to those who had more conventional above-the-knee amputations, participants in a small clinical study also stated that the limb felt more like a part of their own body.

“A prosthesis that's tissue-integrated — anchored to the bone and directly controlled by the nervous system — is not merely a lifeless, separate device, but rather a system that is carefully integrated into human physiology, offering a greater level of prosthetic embodiment. It’s not simply a tool that the human employs, but rather an integral part of self,” 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.

Tony Shu PhD ’24 is the lead author of the paper, which appears today in Science.

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According to a 2024 study, individuals who had below-the-knee amputations and underwent AMI surgery were able to walk more quickly and avoid obstacles far more naturally than those who had undergone conventional below-the-knee amputations.

To better assist those who have had amputations above the knee, the researchers expanded the methodology in the new study.  In order to provide greater stability and improved sensory input, they aimed to develop a system that could be embedded into the bone in addition to employing AMI to read out signals from the muscles.

In order to accomplish that, the researchers devised a method for implanting a titanium rod into the remaining femur bone at the site of amputation.  Compared to a conventional prosthesis, this implant offers superior mechanical control and load bearing.  Furthermore, the implant has 16 wires that gather data from electrodes on the body's AMI muscles, allowing for more precise translation of the impulses originating from the muscles.

A novel robotic controller created especially for this investigation receives AMI signals from this bone-integrated device, called e-OPRA.  The torque required to move the prosthesis in the manner the user desires is determined by the controller using this information.

In this study, two subjects received the combined AMI and e-OPRA system, known as an osseointegrated mechanoneural prosthesis (OMP). These users were compared with eight who had the AMI surgery but not the e-OPRA implant, and seven users who had neither AMI nor e-OPRA. All subjects took a turn at using an experimental powered knee prosthesis developed by the lab.
In addition to testing gait and other movements, the researchers also asked questions designed to evaluate participants’ sense of embodiment — that is, to what extent their prosthetic limb felt like a part of their own body.

Questions included whether the patients felt as if they had two legs, if they felt as if the prosthesis was part of their body, and if they felt in control of the prosthesis. Each question was designed to evaluate the participants’ feelings of agency, ownership of device, and body representation.

The researchers found that as the study went on, the two participants with the OMP showed much greater increases in their feelings of agency and ownership than the other subjects.

“Another reason this paper is significant is that it looks into these embodiment questions and it shows large improvements in that sensation of embodiment,” Herr says. “No matter how sophisticated you make the AI systems of a robotic prosthesis, it’s still going to feel like a tool to the user, like an external device. But with this tissue-integrated approach, when you ask the human user what is their body, the more it’s integrated, the more they’re going to say the prosthesis is actually part of self.”

The AMI procedure is now done routinely on patients with below-the-knee amputations at Brigham and Women’s Hospital, and Herr expects it will soon become the standard for above-the-knee amputations as well. The combined OMP system will need larger clinical trials to receive FDA approval for commercial use, which Herr expects may take about five years.

The research was funded by the Yang Tan Collective and DARPA.

Researchers at The University of Texas at Austin have invented a new noninvasive, wearable sensor designed to measure a user’s hydration levels continuously. Such a device could help a football player stay hydrated on a hot September afternoon, keep a firefighter battling a blaze from getting too dried out, or just let an office worker know when it’s time to refill a water bottle, reports UT News.

“Dehydration is a silent threat that affects millions of people every day,” said Nanshu Lu, a professor in the Cockrell School of Engineering’s Department of Aerospace Engineering and Engineering Mechanics, who led the study published in the Proceedings of the National Academy of Sciences. “Our wearable sensor provides a simple, effective way to monitor hydration levels in real time, empowering individuals to take proactive steps to stay healthy and perform at their best.”

It uses bioimpedance, a technique that measures how electrical signals pass through the body, to track hydration levels. Using strategically placed electrodes, the sensor sends a small, safe electrical current through the arm.
How the electrical current flows through the body depends on the amount of water in the tissues. Water is a good conductor of electricity, so hydrated tissues allow the current to pass more easily, while dehydrated tissues resist the flow.
Data collected by the sensor is wirelessly transmitted to a smartphone, allowing users to monitor their hydration levels.

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Researchers conducted several experiments to test the device, including a diuretic-induced dehydration study and a 24-hour free-living trial. In the dehydration study, participants took a diuretic medication to promote fluid loss, and their hydration levels were monitored using the wearable sensor and then tested against a urine sample. The results showed a strong correlation between changes in arm bioimpedance and body weight loss due to water loss.

“Our experiments demonstrated that arm bioimpedance is not only sensitive to hydration changes but also aligns closely with whole-body hydration measurements,” said Matija Jankovic, co-author of the study and a postdoctoral researcher in Lu’s lab. “This means the sensor can be a reliable surrogate for tracking hydration levels, even during everyday activities like walking, working or exercising.”

Traditional methods for assessing hydration, such as urine tests and blood analysis, are often invasive, time-consuming and impractical for continuous monitoring. Commercial hydration assessment devices typically require bulky equipment and stationary setups, limiting their use in everyday life.
Lu and her team have used similar technology to create sensors to measure other aspects of human health, including:

A sensor to measure stress levels, which could help people working difficult jobs perform at their best.

A conductive ink that can be printed on someone’s head to measure their brainwaves.

Hydration is essential for human health. It plays a critical role in maintaining organ function, regulating body temperature, and supporting vital physiological processes.

In addition to protecting workers in extreme environments, the device has potential applications in health care. Continuous hydration monitoring could aid in diagnosing and managing conditions such as kidney disease, cardiovascular issues and chronic dehydration.

While the current version of the sensor tracks relative changes in hydration, future research aims to establish reference data for absolute hydration levels. This would involve collecting bioimpedance measurements from a large population to create a baseline for comparison.

The researchers also plan to explore new designs, such as breathable e-tattoos and sweat-wicking wearables, to improve comfort and performance during extended use. They hope to expand testing to larger groups and explore applications for other body segments, such as the forearm or thigh.

“This is just the beginning,” Lu said. “Our goal is to make simple hydration monitoring accessible to everyone.”

Singapore-based health tech company Rebee Health raised undisclosed amount of funding from 1337 Ventures through its seed-stage fund, 1337 Capital 1, to scale its AI-powered rehabilitation platform and wearable sensor technology. The investment will enable Rebee to expand into more hospitals, clinics, and homes; strengthen collaborations with healthcare providers; and accelerate the development of AI-driven patient monitoring tools.

“As the demand for rehabilitation grows, innovative solutions like Rebee Health’s wearable technology are critical to improving patient outcomes while reducing strain on healthcare systems. We see Rebee as a game-changer in digital physiotherapy, making recovery more accessible, efficient and scalable,” said Bikesh Lakhmichand, CEO and founding partner of 1337 Ventures.

With the global aging population on the rise, the demand for physical rehabilitation is set to increase dramatically. More individuals will require long-term care for chronic conditions, post-surgical recovery, and injury rehabilitation. However, the rehabilitation ecosystem remains highly complex and expensive, often requiring frequent in-person therapy sessions that place a burden on patients, caregivers and healthcare providers, reports 1337 Ventures.

Wearable sensor technology is being used by Rebee Health to address this issue and transform the rehabilitation process. Real-time, remote physiotherapy sessions are made possible by its physiotherapy system, which increases accessibility, cost effectiveness, and data-driven rehabilitation. The wearable sensor at the heart of Rebee's solution gathers biomechanical data from patients as they exercise.

The patient application receives this data and uses it to track progress and provide real-time insights on when and how to perform exercises correctly. Healthcare professionals can simultaneously watch patients remotely through the therapist web portal, facilitating real-time decision-making and cutting down on needless in-person visits. Significant cost reductions for healthcare institutions could result from the large-scale use of Rebee's system in Singapore.

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“As the demand for rehabilitation grows, innovative solutions like Rebee Health’s wearable technology are critical to improving patient outcomes while reducing strain on healthcare systems. We see Rebee as a game-changer in digital physiotherapy, making recovery more accessible, efficient, and scalable,” said Bikesh Lakhmichand, CEO and founding partner of 1337 Ventures.

With this funding, Rebee Health aims to expand its wearable rehabilitation solutions to more hospitals, clinics, and direct consumers, develop AI-driven rehabilitation to enhance patient engagement and recovery, and strengthen data insights for remote decision-making to improve patient outcomes and reduce costs.

The 1337 Capital 1 Fund is a sector-agnostic seed-stage fund backed by industry leaders like Suresh Thiru, former COO of JobStreet, and successful startup founders. Designed by entrepreneurs for entrepreneurs, the fund provides early-stage startups with funding, mentorship, and strategic guidance, accelerating the next wave of disruptive innovation.

In an attempt to catch up in valve replacements after Boston Scientific's recent global withdrawal, Abbott is stepping up its efforts in the structural heart space.

Sales of its Navitor transcatheter aortic valve replacement implant have doubled in the last two years, mostly due to growth in Europe and globally, according to CEO Robert Ford, and the future appears bright, reports Conor Hale in Fierce Biotech.

Although Edwards Lifesciences and Medtronic are still the biggest companies in the industry, Boston Scientific declared in late May that it will stop pursuing FDA approval and remove its Acurate family of TAVR valves from the market, including those that were just authorized in Europe.

The company said the move followed conversations with overseas regulators and setbacks in a U.S. clinical study.  According to Boston Scientific, accurate valves have been used to treat over 80,000 patients and are available in more than 50 countries.

Related Abbott Receives FDA Clearance for Two CGMs

“There's an opportunity here to accelerate growth internationally, with a competitor market exit,” Ford said on Abbott’s second-quarter earnings call with investors. “I know the team’s all over that, and with the upcoming CE mark that we have planned for Navitor to have a low and intermediate risk label expansion—it could come at a perfect time, to be quite honest with you.”

By the end of this year, Abbott plans to double the size of its associated sales force in comparison to 2024 in an effort to expand its presence in the United States.

“Right now we're in about 20% of the centers in the U.S., and the way to expand our position here is we’ve got to be in more centers. And the way to do that is you need more clinical people, you need more feet on the street,” Ford said. “We’re putting ourselves in the realm of being more competitive, in terms of access to sites.”

Abbott is also developing a new balloon-expandable TAVR implant, with first-in-human procedures completed late last year, that will sit alongside Navitor’s self-expandable approach.

“Once you commit yourself to developing next-generation, balloon-expandable TAVR, that also opens up a nice opportunity for us—even though that'll probably be more towards the end of this decade, in terms of a full launch,” he said.

As an addition to its MitraClip repair system, Abbott received FDA approval last quarter for its Tendyne mitral valve replacement implant, which is not related to TAVR.  Additionally, by 2028, the company intends to build a new cardiovascular device manufacturing facility in Georgia.

A team of Caltech engineers has developed a smart capsule called PillTrek, which can measure pH, temperature, and a variety of different biomarkers. It incorporates simple, inexpensive sensors in a miniature wireless electrochemical workstation that relies on low-power electronics. PillTrek is tiny, measuring 7 millimeters in diameter and 25 millimeters in length, making it smaller than commercially available capsule cameras used for endoscopy but capable of executing a range of electrochemical measurements.

"We designed this pill to be a very versatile platform," says Wei Gao, professor of medical engineering at Caltech and a Heritage Medical Research Institute Investigator. "From an electrochemical-sensing point of view, it is very powerful. It has the ability to measure metabolites, ions, hormones such as serotonin and dopamine, possibly even proteins as well. And all within the gut, which is a complex environment."

The scientists describe the capsule in a new paper in the journal Nature Electronics. The lead authors of the paper are Jihong Min, a postdoctoral scholar fellowship trainee in medical engineering at Caltech, and Hyunah Ahn, a visitor in medical engineering at Caltech and graduate student at the Korea Advanced Institute of Science and Technology (KAIST), reports Caltech.

As a proof of concept, PillTrek was used in the study to measure pH and temperature as well as changing levels of glucose and the neurotransmitter serotonin in animal models.

Gao points out that the electrochemical workstation within the capsule is reconfigurable. A variety of different sensors could easily be swapped into place to enable measurements of different parameters in the gut. His team previously developed a technique for 3D printing inexpensive sensors on sheets of plastic substrate. That technique can be used to mass-produce the sensors for PillTrek.

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In terms of next steps, Gao says that he is working with co-author Azita Emami, the Andrew and Peggy Cherng Professor of Electrical Engineering and Medical Engineering at Caltech, to look into wireless power transfer and smaller electronics that would make PillTrek even smaller and lower power.

"Ingestible capsules have significant potential in diagnosis, monitoring, and management of chronic conditions, but previous devices were very limited in terms of their sensing capabilities, lifetime, and size," says Emami, who is also director of the Center for Sensing to Intelligence. "This work is an important translational step toward devices that can provide meaningful medical information for patients and physicians."

Samsung Electronics today introduced Galaxy Watch8 and Galaxy Watch8 Classic, establishing an iconic design identity across the entire Galaxy Watch lineup. Building upon the foundation of the Galaxy Watch Ultra’s cushion design, this series boasts the thinnest, most comfortable Galaxy Watch ever for continuous health tracking. The Galaxy Watch8 series suits diverse lifestyles and provides advanced capabilities, setting a new standard for style and personalized health experiences.

“We are committed to empowering billions of people to live healthier lives through our innovative technology,” said TM Roh, President and Acting Head of the Device eXperience (DX) Division at Samsung Electronics. “By combining purposeful design with advanced sensor technology and an intuitive AI-powered experience, the Galaxy Watch8 series serves as a starting point for a healthier, more connected life, making it easier than ever to take meaningful steps toward users’ well-being.”

Redesigned Inside and Out for Ultimate Wellness

Galaxy Watch8’s sleek profile is complemented by its exceptional performance. Even when you are outdoors under bright sunlight, the display is 50% brighter with a peak brightness of 3,000nits for easy visibility, and the enhanced battery ensures the watch can keep up with an active lifestyle. Moreover, the dual-frequency GPS provides more detailed and precise location results while our most powerful 3nm processor delivers faster performance and greater power efficiency. With the groundbreaking BioActive Sensor that enables deeper and more accurate health insights, the Galaxy Watch8 series helps provide a holistic view of your health, Samsung said in a press release.

Motivation for Lasting Health Changes

Sleep is a window into your overall health and each restful night allows your body and mind to recover immediately the very next day. That’s why Samsung is continuously advancing the sleep experience, offering tailored sleep coaching, helping to create an optimal sleep environment, and even detecting moderate to severe signs of sleep apnea. On top of that, the Galaxy Watch8 series comes with new unique health features on the Samsung Health app that help you build healthier habits through instant, motivational insights – from sleep to nutrition and workout.

Bedtime Guidance can measure your circadian rhythm to suggest the optimal time to go to bed so you wake up refreshed the next morning. Vascular Load helps monitor the stress levels on your vascular system during sleep. Providing insights on various lifestyle factors including sleep, stress and activity, it helps you adopt a more comprehensive approach to managing your health.

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Meanwhile, the Galaxy Watch8 series introduces Antioxidant Index for the first time in a smartwatch, enabling you to measure carotenoid levels in just five seconds and make informed lifestyle choices for healthy aging.

Whether you’re a novice or experienced runner, the Galaxy Watch8 series delivers personalized fitness insights to keep you motivated when you need it most. Running Coach calculates your fitness level from 1 to 10 and develops a tailored training plan complete with real-time guidance and motivational insights. With the updated Together feature, which now supports running, you can gamify your fitness journey by challenging friends and family.

If high level of stress persists, High Stress Alert will immediately signal so that you can take a break to help manage your stress levels in real-time. With Mindfulness Tracker, you can record your mood and receive guidance on breathing exercises to relieve your stress – all at once on your wrist.

Plus, the AI-powered Energy Score gives you a snapshot of your energy level, combining physical and mental energy metrics so you can have a healthier day, every day.

Easier Watch Interaction With Wear OS and Gemini

Developed in close collaboration with Google, the Galaxy Watch8 series is the first smartwatch to come out of the box with Gemini, Google’s AI assistant, and be powered by Wear OS 6. Go hands-free using natural voice commands to get things done on the go with your Galaxy Watch apps like Samsung Health, Calendar, Reminder and Clock. For example, you can ask Gemini to find a nearby cafe and text a friend to meet you there, all in one go. Or, if you’re ready to start your workout and you have a goal in mind, simply say, “Start a 30-minute run.” The watch seamlessly initiates the workout in Samsung Health.

Tailored To Match Every Lifestyle

Galaxy Watch8, Galaxy Watch8 Classic and the new Galaxy Watch Ultra are available for pre-order in select markets starting today, with general availability starting July 25.

Featuring a sleek and minimalist design, Galaxy Watch8 is designed for everyday wellness. Available in 44mm or 40mm sizes and in Graphite or Silver, it provides comfort and style for daily activities. Meanwhile, Galaxy Watch8 Classic brings timeless sophistication to the wrist with modern features such as a rotating bezel and a quick button for added convenience. The Classic model measures 46mm and comes in Black and White. Plus, both models can be matched with a range of stylish band designed to suit diverse lifestyles.

For those who love outdoor adventures, Galaxy Watch Ultra is the most advanced and durable Galaxy Watch model yet. Available in four titanium finishes including the new Titanium Blue, it offers the longest battery life and the most robust performance in the lineup.

If you’re looking for a more discreet wearable that offers continuous health tracking, Galaxy Ring boasts superior comfort and up to seven days of battery life. Available in Titanium Black, Titanium Silver and Titanium Gold, the Galaxy Ring comes in sizes 5-15.

Hypoglycemia, or low blood sugar, is a constant risk for those who have Type 1 diabetes.  Injecting a hormone called glucagon is the mainstay of care for life-threatening situations caused by extremely low glucose levels.

MIT engineers have created an implantable reservoir that can stay beneath the skin and be set to release glucagon when blood sugar levels fall too low as an emergency backup in situations where patients might not be aware that their blood sugar is dangerously low.

This approach could also help in cases where hypoglycemia occurs during sleep, or for diabetic children who are unable to administer injections on their own, reports MIT.

“This is a small, emergency-event device that can be placed under the skin, where it is ready to act if the patient’s blood sugar drops too low,” says Daniel Anderson, a professor in MIT’s Department of Chemical Engineering, a member of MIT’s Koch Institute for Integrative Cancer Research and Institute for Medical Engineering and Science (IMES), and the senior author of the study. “Our goal was to build a device that is always ready to protect patients from low blood sugar. We think this can also help relieve the fear of hypoglycemia that many patients, and their parents, suffer from.”

Related Breakthrough in Continuous Glucose Monitoring

The researchers demonstrated that epinephrine, a medication used to treat heart attacks and prevent severe allergic reactions, including anaphylactic shock, could also be administered in an emergency using this device.

The study, which was published in Nature Biomedical Engineering, was led by Siddharth Krishnan, a former research scientist at MIT who is currently an assistant professor of electrical engineering at Stanford University.

To assist their bodies absorb sugar and keep their blood sugar levels from rising too high, the majority of patients with type 1 diabetes receive insulin injections every day. But if their blood sugar levels go too low, they develop hypoglycemia, which can cause seizures and confusion and, if left untreated, can be lethal.

Some patients carry preloaded glucagon syringes, which stimulate the liver to release glucose into the bloodstream, to help fight hypoglycemia. People, particularly kids, don't always recognize when they are getting hypoglycemia, though.

To make it easier to counteract hypoglycemia, the MIT team set out to design an emergency device that could be triggered either by the person using it, or automatically by a sensor.

The device, which is about the size of a quarter, contains a small drug reservoir made of a 3D-printed polymer. The reservoir is sealed with a special material known as a shape-memory alloy, which can be programmed to change its shape when heated. In this case, the researcher used a nickel-titanium alloy that is programmed to curl from a flat slab into a U-shape when heated to 40 degrees Celsius.

Each device can carry either one or four doses of glucagon, and it also includes an antenna tuned to respond to a specific frequency in the radiofrequency range. That allows it to be remotely triggered to turn on a small electrical current, which is used to heat the shape-memory alloy. When the temperature reaches the 40-degree threshold, the slab bends into a U shape, releasing the contents of the reservoir.

Because the device can receive wireless signals, it could also be designed so that drug release is triggered by a glucose monitor when the wearer’s blood sugar drops below a certain level.

After implanting the device in diabetic mice, the researchers used it to trigger glucagon release as the animals’ blood sugar levels were dropping. Within less than 10 minutes of activating the drug release, blood sugar levels began to level off, allowing them to remain within the normal range and avert hypoglycemia.

The researchers also tested the device with a powdered version of epinephrine. They found that within 10 minutes of drug release, epinephrine levels in the bloodstream became elevated and heart rate increased.

In this study, the researchers kept the devices implanted for up to four weeks, but they now plan to see if they can extend that time up to at least a year.

“The idea is you would have enough doses that can provide this therapeutic rescue event over a significant period of time. We don’t know exactly what that is — maybe a year, maybe a few years, and we’re currently working on establishing what the optimal lifetime is. But then after that, it would need to be replaced,” Krishnan says.

Meta and Oakley are collaborating to deliver a brand-new category of Performance AI glasses.

Oakley Meta glasses are a new product line that will combine Oakley’s signature design DNA with Meta’s industry-leading technology to give you deeper insights into your physical capabilities and help you share your biggest wins – on and off the field. The line will launch in a new global campaign starring Team Oakley athletes: World Cup winner Kylian Mbappé and three-time Super Bowl MVP Patrick Mahomes.

Related Journey Frame – The Smart Eyewear for a Distracted World

Glasses have emerged as a major new hardware category of the AI era. Meta said they are proud to lead the market with Ray-Ban Meta glasses, which have sold millions of units since launch. And now, they are expanding their partnership with EssilorLuxottica to build upon another iconic, global brand.  

“Our first product for athletes and fans alike, Oakley Meta HSTN (pronounced HOW-stuhn), based on the HSTN style of Oakley glasses, combines bold aesthetics with cutting-edge tech. Capture the action completely hands-free with the built-in camera and share your unique POV. Get pumped up with your favorite playlist, listen to podcasts and more, thanks to powerful open-ear speakers seamlessly integrated into the frames. And with an IPX4 water resistance rating, you can push yourself to the outer limits of your potential,” Meta said in a press release.

Oakley Meta HSTN is taking the game to the next level with features that represent the evolution of AI glasses:    

• More battery stamina: A fully charged pair of Oakley Meta HSTN glasses can last up to eight hours of typical use and up to 19 hours on standby. You can charge them up to 50% in just 20 minutes. The glasses also come with a charging case that can deliver up to 48 hours of charging on the go.

• Higher resolution camera: Capture your activity and share your achievements in Ultra HD (3K) video.

• Meta AI meets Performance AI glasses: With Meta AI, your personal AI assistant, built in, athletes can get more out of their Oakley Meta HSTNs right out of the box. For example, you can level up the competition in a whole new way when playing a round of golf. Need to know how the wind is going to affect your drive? Ask, “Hey Meta, how strong is the wind today?” and channel your inner Team Oakley Athlete J.R. Smith. Or, like Boo Johnson, record epic moments and post to Stories, hands-free, by saying, “Hey Meta, take a video.” Get answers to a range of questions, whether you’re improving your game or checking the surf conditions.

Product Availability

The Limited-Edition Oakley Meta HSTN will be available for preorder starting July 11 for $499 USD, with the rest of the collection starting at $399 USD dropping later this summer. Oakley Meta HSTN will be available in the US, Canada, UK, Ireland, France, Italy, Spain, Austria, Belgium, Australia, Germany, Sweden, Norway, Finland and Denmark. We’re also working to bring Oakley Meta HSTN to Mexico, India, and the United Arab Emirates later this year.

In a world where smartwatches and step counters are commonplace, a new generation of wearable technology is entering the market to safeguard your fitness rather than track it.

The Urban Eyes vest is a stylish piece of new equipment that recognizes your presence and doesn't merely glow in the dark.
The 390-gram (0.9-lb) wearable device was invented five years ago by British entrepreneur Tony Rossiter, after his daughter told him about being followed by a man when she was out running. Fast-forward to 2025, and a new second-generation version of the product is now available for preorder, reports New Atlas.

Simple in design, the lightweight, breathable base garment has an adjustable waistband, high-visibility colored panels, and reflective piping. In addition, there are two smaller zipped pockets on the shoulder straps and a sizable smartphone pocket over the tummy.

The Urban Eyes' dual 2.5K/30fps wide-angle front and rear cameras are what set it apart. These are made to be visually striking since each one has a bright white body that is 60 mm (2.4 in) broad and mounts inside a black eye-shaped container that contrasts with it. Each camera also has a blue LED that flashes while it records sound and images.

Read more Splashtop Unveils AR Support System

With a single button click on a small wireless remote, both cameras' simultaneous recording can be started and stopped. Additionally, the wearable can be utilized to snap still images as necessary and to pause recording. Each camera stores footage on SD cards, and it has been stated that a single charge of the cameras' batteries lasts for 90 minutes.

Rossiter made the decision not to go with the current self-contained recording technology, even though there would undoubtedly be some benefits to having the video automatically upload to the cloud via an app.

"Many runners expressed a preference for a plug-and-play solution, as it provides greater flexibility," he tells us. "For instance, an app-based system might encounter network issues while they're out running, potentially disrupting their experience. In contrast, our current setup with the SD card and the newly introduced remote control allows users to maintain complete control over the vest."

The Urban Eyes vest can be preordered now via the company website in a choice of five panel colors, at a price of £150 (about US$204). It should take about 35 days to arrive. The following video provides a demo of its features.

Facebook parent company Meta strengthened its ties to the rapidly expanding smart glasses market by purchasing a minority share in EssilorLuxottica SA, the largest eyewear producer in the world.

According to insiders who asked not to be named since the discussions are confidential, Meta purchased little under 3% of the Ray-Ban manufacturer, which is a stake worth about €3 billion ($3.5 billion) at market pricing.

According to the sources, Meta, a Menlo Park, California-based company, is thinking about making more investments that would eventually increase its ownership to about 5%, though those plans could alter, reports Yahoo Finance.

Shares of EssilorLuxottica surged the most in three months in Paris. The growing ties with Meta should be seen as a vote of confidence in the eyewear maker and the opportunity in eyeglasses, according to analysts at Bernstein.

“This represents another step in Meta’s commitment to the smart-glasses category,” the analysts said in a research note.

The two companies have been collaborating on AI-powered smart eyewear for a number of years. A pair of Ray-Ban glasses with built-in cameras and an AI assistant that can deliver real-time stock quotes or image captioning was initially introduced in 2021 and is currently sold by Meta.

Related Meta’s Aria Gen 2 Research Glasses

Meta and EssilorLuxottica introduced different Oakley-branded eyewear last month.  Francesco Milleri, the CEO of the eyewear company, stated last year that Meta was considering purchasing a portion of EssilorLuxottica; however, this plan has yet to come to fruition.

On Wednesday, EssilorLuxottica's market value was €117.3 billion, up as high as 7.1%.  In US premarket trade, Meta increased by less than 1%.

Following the Bloomberg story, Warby Parker, a rival eyeglass manufacturer, had a 4.5% increase in the US on Tuesday.

The deal is in line with Mark Zuckerberg, the CEO of Meta, who has made AI a top goal and significant investment for the business. One important component of such strategy is smart eyewear.

According to Zuckerberg, glasses give Meta the opportunity to develop its own hardware and manage its own distribution, whereas in the past it has been forced to distribute its programs and services through smartphones made by other companies.

Because of the arrangement, Meta has access to worldwide distribution networks and more in-depth production skills, which are essential for transforming its smart glasses into mass-market goods.

If Meta's forward-thinking investments prove successful, the merger gives EssilorLuxottica a stronger foothold in the tech sector. Additionally, Meta is placing a wager on the notion that people will eventually work and play while using glasses or headsets.

Although they provide information, so-called non-AR smart glasses don't offer a complete alternate reality experience that would change how users perceive their surroundings. The Bernstein analysts stated that since complete AR is "some years away from being practical," Apple Inc. has also lately shifted to non-AR smart glasses.

GrandView Research projects that the smart glasses industry will increase from $1.93 billion in 2024 to $8.26 billion by 2030.

Ambiq Micro, a provider for ultra-low-power semiconductor solutions for edge AI, announced that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (the “SEC”) relating to the proposed initial public offering of its common stock. The proposed offering is subject to market and other conditions and there can be no assurance as to whether or when the proposed offering may be completed. The number of shares of common stock to be offered and the price range for the proposed offering have not yet been determined. Ambiq intends to apply to have its common stock listed on the New York Stock Exchange under the symbol “AMBQ.”

Read more Ambiq Empowers Digital Health with Edge AI

BofA Securities and UBS Investment Bank will act as joint lead book-running managers for the proposed offering. Needham & Company and Stifel will act as joint book-running managers for the proposed offering, Ambiq said in a press release.

“A registration statement relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction,” the company said.

About Ambiq

Founded in 2010, Ambiq Micro provides ultra-low-power semiconductor solutions, targeting the power consumption challenges of general-purpose and AI computing. Ambiq’s mission is to enable artificial intelligence everywhere by delivering the lowest power semiconductor solutions. Ambiq enables its customers to deliver AI compute at the edge where power consumption challenges are the most profound. Ambiq’s technology innovations, built on the patented and proprietary subthreshold power optimized technology (SPOT), fundamentally deliver a multi-fold improvement in power consumption over traditional semiconductor designs. Ambiq has powered over 270 million devices to date.

Peri, a new wearable device designed to track perimenopause symptoms, was unveiled at CES 2025. The device, developed by identifyHer, focuses on providing women with objective data and personalized insights into their perimenopausal experience. Peri is designed to be worn on the torso, allowing it to capture "digital fingerprints" that are more indicative of perimenopause symptoms than traditional wrist-worn wearables.

The term "perimenopause" describes the time leading up to menopause when the ovaries gradually quit functioning. When hormones like progesterone and estrogen start to decline, mood swings, irregular periods, hot flashes, and night sweats may result. Though it might be as short as a few months or as long as ten years, perimenopause symptoms can vary greatly from person to person and typically last four to eight years, reports The Verge.

Peri is a discreet and unobtrusive wearable device that passively tracks perimenopausal symptoms from the surface of the skin. Along with the companion app, Peri captures objective symptom and lifestyle data to provide personalized insights that empower you to unlock your greatest potential in perimenopause and beyond.

Related Movano’s Evie Ring for Women

According to the company’s press release, the device will provide “objective data on perimenopausal symptoms, lifestyle, and sleep, as well as actionable insights and encouragement to better understand the changes their bodies are undergoing.” In official pictures, the device itself appears to be pill-shaped and adheres to a person’s torso as opposed to their wrist or finger, like most other health trackers.

“We will keep the specific sensors confidential until we open pre-orders,” says Peri cofounder Heidi Davis, though Davis acknowledges that none of the sensors in the device are new or proprietary. “Our breakthrough lies in the digital fingerprints we have identified through three years of R&D, collecting sensor data from women experiencing perimenopause.”

Davis says, the "fingerprints" were subsequently utilized to create algorithms that offer ongoing information on perimenopausal women's anxiety, hot flashes, and nocturnal sweats.  According to Davis, one unexpected discovery is that body temperature isn't a good predictor of hot flashes.  Additionally, extra care was taken to make sure that factors like exercise or warm weather, which might alter body temperature, sweating, or heart rate, wouldn't influence the algorithms.
Davis says identifyHer also intentionally decided to forgo a limb-based tracker.

“During the early stages of development, we tested our sensors on the limbs but found that we could not identify the digital fingerprints for some of the typical symptoms of perimenopause,” Davis explains, noting that the torso delivers the most accurate readings and is where hot flashes and night sweats are strongest.

For Kunde, a blind dog, a group of researchers at Rice University has created a haptic feedback vest and camera system. The researchers hope that the vest will soon help other puppies navigate the challenges they face on a regular basis.

A significant percentage of elderly dogs will eventually go blind, whether due to glaucoma, diabetes problems, cataracts, or a variety of other injuries and illnesses. Even though a lot of dogs may eventually learn to traverse their environment without seeing, canines frequently knock into furniture and walls during this process, which is annoying for both dog owners and their closest friends, reports New Atlas.

The owners of Kunde, a dog from Houston, turned to Oshman Engineering Design Kitchen, an engineering design maker space at Rice University, for assistance after Kunde became blind from glaucoma. Kunde was lucky that four young students heeded the call.

Related Dog Collar Tracks Behavior & Health

The scientists created a wearable system for the dog that included a vest and a set of stereoscopic cameras placed close to his head, building on an earlier system that employed LiDAR for navigation.  Small actuator motors in the vest receive signals from the cameras, which are far less expensive than the LiDAR system, regarding impediments in the dog's route and vibrate in response.  The vibration intensifies with the dog's proximity to an obstruction.

“Kind of like giving Kunde a second set of eyes, the cameras create a depth map,” said Issy Tsai, a freshman electrical engineering major who designed the team’s custom printed circuit board, which sends the signals from the camera to the vest.

Kunde is currently testing the system after figuring out how to keep it lightweight and weatherproof, both in terms of rain and the intense heat that is typical in Houston.  The finished prototype has a battery life of roughly two hours and can "see" up to 8 meters (26 feet).

“The team has made exciting progress, and while there’s still more development ahead to fully meet the client’s needs, they’ve already demonstrated the power of having a real-world challenge to drive meaningful design,” added team mentor, Heather Bisesti. “It’s motivating for students to see how their work can make a direct difference in someone’s ⎯ or some dog’s ⎯ life.”

The researchers intend to use the knowledge they have gained from working with Kunde to create a navigation system that will eventually enable other blind canines to flourish in their surroundings.

Aktiia, a pioneer in optical blood pressure monitoring, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for over-the-counter (OTC) use of its cuffless blood pressure monitoring technology. This clearance, granted for Aktiia’s G0 Blood Pressure Monitoring System, marks the first time the FDA has cleared a cuffless blood pressure monitor indicated for over-the-counter (OTC) use in the United States. While Aktiia's innovative blood pressure monitoring products are already CE marked and available in Europe under the brand Hilo, the product will be made available to US consumers in 2026.

Trusted by over 130,000 users globally, the Hilo Band has demonstrated the impact of Aktiia’s technology in real-world settings. With this FDA clearance, consumers in the U.S. will soon have access to the same clinically validated innovation behind the Hilo Band and app. With no medical prescription required, it is now the first cuffless blood pressure monitor authorized for over-the-counter use in the United States. The milestone sets a new global benchmark for how blood pressure can be effortlessly monitored through wearable, user-friendly technology. With this FDA clearance, Aktiia is now positioned to establish Hilo as the category-defining wearable for cuffless blood pressure monitoring in the U.S. and beyond.

“This is not just a regulatory win: it’s the start of a paradigm shift in hypertension management,” said Josep Sola, Co-Founder and CTO of Aktiia.
“With FDA’s OTC clearance, we are breaking down the barriers that have kept cuffless blood pressure monitoring out of the hands of millions.”

“This milestone is the result of more than seven years of relentless scientific, clinical, and engineering effort,” said Mattia Bertschi, Co-Founder of Aktiia.
“What began as a research vision in the Swiss Research Institute CSEM twenty years ago has now become the world’s first cuffless, FDA-cleared, over-the-counter solution for blood pressure – and we’re just getting started.”

This regulatory clearance follows an oversubscribed Series B round of over $42 million USD co-led earlier this year by Earlybird Venture Capital and Wellington Partners.

“Aktiia’s FDA clearance represents a breakthrough moment for medical-grade wearables,” said Dr. Christoph Massner, Principal at Earlybird and Board Director of Aktiia.
“We backed the team because they combined bold vision with scientific rigor; and today they’ve delivered what no one else could. The Hilo Band is poised to lead a global transformation in how we understand and manage cardiovascular health at scale.”

The Hilo Band is not just another wearable: it is the first of its kind blood pressure companion, marking a breakthrough moment for cardiovascular health, much like the iPhone did for mobile technology. Due to its sleek, lightweight and comfortable form factor, the Hilo Band ushers in a new class of medical wearables that empower individuals to monitor their blood pressure anytime, anywhere. Achieving this milestone reinforces Aktiia’s leadership in cuffless, consumer-ready blood pressure monitoring, redefining what’s possible in everyday cardiovascular care.‍

About Aktiia‍

Founded in 2018, Aktiia is transforming the way blood pressure is measured and managed. By harnessing one of the world’s largest datasets of optical signals, its cuffless monitoring product (commercially known as the Hilo Band) provides clinically meaningful insights to both individuals and healthcare professionals, making blood pressure tracking more accessible and effortless than ever before.

With billions of optical signals and hundreds of millions of blood pressure readings collected from over 130,000 users, Aktiia has developed a robust and scalable solution to address one of the world’s most pressing health challenges. Hypertension affects more than 1.3 billion people globally and remains the leading risk factor for cardiovascular disease; yet most cases remain undiagnosed or poorly managed. By enabling seamless and user-friendly monitoring at home, Aktiia is poised to transform how hypertension is detected and managed worldwide.

Backed by a multidisciplinary team with deep expertise in biomedical signal processing and machine learning, Aktiia’s innovation is supported by more than 120 peer-reviewed publications and over 35 patents. Headquartered in Switzerland, the company is expanding internationally to make accessible, cuffless blood pressure monitoring the new standard of care in home hypertension management.

Note: The Hilo Band requires calibration using a cuff, which is provided with the purchase. The Hilo system by itself is not intended to make diagnoses. Data should always be used in consultation with your healthcare provider.