Tinnitus sufferers can regain their sense of silence with the use of ForgTin®. The annoying ear noises can be diminished—or even eliminated—by applying gentle pressure stimulation to specific locations around the ear.

The symptom of tinnitus is the sense of sound when there are no external stimuli. Millions of people experience tinnitus on a regular basis; epidemiologic studies have revealed that its prevalence ranges from 8% to 25.3% of the US population. ForgTin® by Pansatori effectively lowers tinnitus. Light pressure stimulation can lessen bothersome ringing in the ears.

What we especially like about ForgTin® is that their product is backed up by science!

A study showed that within six weeks,

• A decrease in the volume of the subjectively felt tinnitus was observed in roughly 39% of all ForgTin® users.
• Approximately 41% of all ForgTin® users reported less jaw tension.
• It resulted in a decrease in neck stress in 39% of people.
• In addition, 40% of ForgTin® users showed a significant decrease in their individual felt stress levels.

You would like to learn more about ForgTin®? Do not miss the chance to meet them at the WT Pavilion at MEDICA 2022 from the 14-17^th of November!

BIOTRONIK announced today its partnership with AliveCor, a leading innovator in FDA-cleared personal electrocardiogram(ECG) technology and services. This partnership will combine the strengths of BIOTRONIK's BIOMONITOR Injectable Cardiac Monitor (designed with industry-leading 95.1% p-wave visibility1 across all cardiac cycles and 5.5-year longevity) with AliveCor's AI-enabled, clinically validated, medical-grade KardiaMobile 6L and KardiaMobile Card ECG technology. Through this pilot collaboration, healthcare providers will be able to access clinically relevant heart rhythm analyses and actionable reports to monitor at-risk patients; identify underlying arrhythmias, including atrial fibrillation (AF); and assessments to drive improvements in patient care and clinical outcomes.

Read more: New, smart, dissolving, and communicating pacemaker

Up to 25% of stroke patients present with AF2, the most common type of treated cardiac arrhythmia. Historically, screening options for early AF detection have been limited. Pairing AliveCor's KardiaMobile ECGs with BIOTRONIK's implantable device data strives to streamline workflow by providing comprehensive visibility within a single solution.

Until now, remote personal monitoring data and implantable device data have rarely been integrated, making it difficult for healthcare providers to access the full range of patient data. "Our FDA-cleared ECG technology paired with BIOTRONIK's implantable devices for cardiac rhythm diagnostics will allow a holistic view of the patient's heart health on the go while providing critical insights for physicians," said Vincent Balsamo, Executive Vice President of Global Sales at AliveCor, as a press release states.

"Connecting wearable and implantable cardiac diagnostic device data from the earliest stages in the care continuum is groundbreaking," said Kenneth Nelson, Head of Digital Health and Diagnostics at BIOTRONIK. "This pilot project intends to give physicians and caregivers a more longitudinal view of the patient's condition while simultaneously reducing the overall time spent on data management. We are proud to be on the frontier driving novel innovation."

This partnership aims to enable faster diagnosis, more informed clinical decision-making, and effective treatment by bringing complete information to every step in the diagnosis, device implant, and management process. Providing connected solutions with EHR-integrated monitoring may facilitate seamless sharing of secure ECG data to optimize physicians' workflow. "BIOTRONIK is pioneering a digital health ecosystem that is long overdue in the cardiac device industry," said Raul Weiss, MD, FHRS, FACC, Professor of Clinical Medicine, Cardiologist, Director, Electrophysiology Fellowship Program, Ohio State University Medical Center.

This pilot collaboration is the first in a series of partnerships with leading digital health organizations to improve the delivery of connected care in cardiac diagnostics and remote patient monitoring.

About BIOTRONIK

BIOTRONIK is a leading medical device company that has developed trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and is represented in over 100 countries.

About AliveCor

AliveCor, Inc. is transforming cardiological care using deep learning. The FDA-cleared KardiaMobile device is the most clinically-validated personal ECG solution in the world. KardiaMobile 6L provides instant detection of Atrial Fibrillation, Bradycardia, Tachycardia, Sinus Rhythm with Supraventricular Ectopy, Sinus Rhythm with Premature Ventricular Contractions, Sinus Rhythm with Wide QRS, and Normal Sinus Rhythm in an ECG. Kardia is the first AI-enabled platform to aid patients and clinicians in the efficient detection of atrial fibrillation, the most common arrhythmia and one associated with a highly-elevated risk of stroke. AliveCor's enterprise platform allows third-party providers to manage their patients and customers' heart conditions simply using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies.

Artificial Intelligence may soon help doctors diagnose and treat diseases, including cancer and depression, based on the sound of a patient’s voice, as 12 leading research institutions launch a landmark National Institutes of Health-funded academic project that may establish voice as a biomarker used in clinical care.

The University of South Florida in Tampa, FL, is the lead institution on the project in collaboration with Weill CornellMedicine in New York City, 10 other institutions in the United States and Canada, and French-American AI biotech startup Owkin. The first year of the project includes $3.8 million from the NIH, with subsequent funding over the following three years contingent upon annual NIH appropriations by Congress that could bring the overall award to $14 million, reports Owkin.

Called Voice as a Biomarker of Health, the project is one of several recently funded by the NIH Common Fund’s Bridge2AI program, which is designed to use AI to tackle complex biomedical challenges. The voice project will aim to build an ethically sourced database of diverse human voices while protecting patient privacy. Using this data, machine learning models will be trained to spot diseases by detecting changes in the human voice, which could empower doctors with a low-cost diagnostic tool to be used alongside other clinical methods.

Based on the existing literature and ongoing research, the research team has identified five disease cohort categories for which voice changes have been associated with specific diseases with well-recognized unmet needs. Data collected for this project will center on the following disease categories:

• Voice disorders: (laryngeal cancers, vocal fold paralysis, benign laryngeal lesions)
• Neurological and neurodegenerative disorders (Alzheimer’s, Parkinson’s, stroke, ALS)
• Mood and psychiatric disorders(depression, schizophrenia, bipolar disorders)
• Respiratory disorders(pneumonia, COPD)
• Pediatric voice and speech disorders (speech and language delays, autism)

Although preliminary work with voice data has been promising, limitations to integrating voice as a biomarker in clinical practice have been linked to small datasets, ethical concerns around data ownership and privacy, bias, and lack of diversity of the data. To solve these, the Voice as a Biomarker of Health project is creating a large, high-quality, multi-institutional, and diverse voice database that is linked to identity-protected/unidentifiable biomarkers from other data, such as demographics, medical imaging, and genomics. Federated learning technology – a novel AI framework that allows machine learning models to be trained on data without the data ever leaving its source – will be deployed across multiple research centers by Owkin to demonstrate that cross-center AI research can be conducted while preserving privacy and security of sensitive voice data.

Supported by AI experts, bioethicists, and social scientists, the project aims to transform our fundamental understanding of diseases and introduce a revolutionary new method of diagnosing and treating diseases in clinical settings. As the human voice is low-cost, easy to store, and readily available, diagnosing diseases through the voice using AI could prove a transformative step in precision medicine and accessibility.

Read more: Partnership to Integrate Voice Biomarker for Mental Health

“Voice has the potential to be a biomarker for several health conditions. Creating an effective framework that incorporates huge datasets using the best of today’s technology in a collaborative manner will revolutionize the way that voice is used as a tool for helping clinicians diagnose diseases and disorders,” said Dr. Bensoussan, assistant professor in the Department of Otolaryngology and director of USF Health Voice Center at the USF Health Morsani College ofMedicine.

Dr. Elemento, director of the EnglanderInstitute for Precision Medicine and a professor of physiology and biophysics at Weill Cornell Medicine, said that:

The potential for using voice and sounds together with advanced AI algorithms to accurately diagnose certain diseases is incredible. Our future findings could lead to a revolution in health care where continuous voice monitoring could alert physicians earlier than currently possible to certain conditions, such as infections or neurological diseases.

Thomas Clozel MD, co-founder and CEO ofOwkin, said that:

By using AI to analyze minute changes in the human voice, we aim to help doctors to diagnose and treat diseases ranging from cancer to depression. Vocal biomarkers are set to play an increasingly important role in healthcare. We are excited to be using federated learning, our privacy-preserving AI framework, to connect the medical world together in the pursuit of improving outcomes for patients.

About Owkin

Owkin is a French-American startup that uses artificial intelligence to find the right treatment for every patient. Our focus is to use AI to discover and develop better treatments for unmet medical needs, starting with the fight against cancer. We use AI to identify new drug candidates, de-risk and accelerate clinical trials and build diagnostic tools that improve patient outcomes. Using federated learning, a pioneering collaborative AI framework, Owkin enables medical and biopharma partners to unlock valuable insights from siloed datasets while protecting patient privacy and securing proprietary data. Owkin was co-founded by Thomas Clozel MD, a former assistant professor in clinical onco-hematology, and Gilles Wainrib, a pioneer in the field of machine learning in biology, in 2016. Owkin has raised over $300 million and became a unicorn through a $180 million investment from biopharma company Sanofi in November 2021.

Bose Corporation and Lexie Hearing, a direct-to-consumer hearing aid provider in the United States, announced a partnership to bring Bose’s self-fitting hearing aid technology to the Lexie Hearing product line. The new Lexie B1 Hearing Aids will be Powered by Bose, allowing wearers to fit, program, and control their hearing aids with clinically proven, audiologist-quality results — without a doctor visit, hearing test, or prescription.

“We selected Lexie Hearing as our partner to continue to deliver our industry-redefining technology because of our shared mission to make hearing aids more accessible and affordable. Their understanding of the complex, regulated hearing aid market, and ability to reach more of the millions of people who suffer from hearing loss today was also critical to our decision,” said Nick Smith, senior vice president of Bose strategy and business development. “Bose remains committed to developing technologies and innovative experiences that improve how people hear the world around them.”

Read more: Audibel Launches AI-Enabled Hearing Aids

“This partnership with Bose represents an exciting evolution for Lexie Hearing and its commitment to making hearing healthcare accessible to everyone, everywhere,” said Nic Klopper, founder and CEO of Lexie Hearing and hearX Group. “The Lexie B1 Hearing Aids Powered byBose are one of the most revolutionary devices of its kind, marrying convenience and customer service with Bose’s groundbreaking self-fitting technology and customization. By offering top-quality products like these, especially as the FDA prepares to permit the sale of over-the-counter hearing aids this year, we will give more people control of their hearing.”

With this new partnership, BoseSoundControl™ Hearing Aids will no longer be manufactured or sold. Bose will continue to support customers who have previously purchased the product. The Lexie B1 Hearing Aids Powered by Bose will cost $899 — a fraction of the price of most traditional hearing aids — and will be available at lexiehearing.com starting today, reports BusinessWire.

About Bose Corporation

Bose Corporation was founded in 1964 by Dr.Amar G. Bose, then a professor of electrical engineering at the Massachusetts Institute of Technology. Today, the company is driven by its founding principles, investing in long-term research to develop new technologies with real customer benefits. Bose innovations have spanned decades and industries, creating and transforming categories in audio and beyond. Bose products for the home, in the car, on the go, and in public spaces have become iconic, changing the way people listen to music.

About Lexie Hearing

Lexie Hearing, developed by hearX Group, is an innovative game-changer in the U.S. hearing aid market, on a mission to make better hearing affordable and accessible to everyone. The team at Lexie is passionately committed to helping people enjoy healthy hearing without having to spend thousands of dollars, recognizing that too many people do not wear hearing aids because they are so expensive. Lexie brings a great experience to customers with high-quality hearing aids, world-class customer support, and smart technology that gives customers control of their hearing experience.

Insulet Corporation, the global leader in tubeless insulin pump technology with its Omnipod® brand of products, announced its Omnipod 5 Automated Insulin Delivery System is now fully available through U.S. retail pharmacy channels for individuals aged six years and older with type 1 diabetes.

“With the significant demand for our tubeless AID system and impressive clinical outcomes, we continue to expand access to Omnipod 5 and provide a best-in-class experience to more people with type 1 diabetes,” said Bret Christensen, Insulet Chief Commercial Officer. “Through our team’s learnings from the limited market release, we have met our timeframe and goals. We are thrilled to announce that Omnipod 5 is now fully available through retail, specialty, and mail-order pharmacies to anyone with a prescription and coverage.”

Omnipod 5 is the first tubeless AID system in the U.S. that integrates with the Dexcom G6 CGM system to help protect against high and low glucose levels 1. It is also the only tubeless AID that offers the option of using a compatible smartphone or the separate Omnipod 5 Controller, which is provided to every customer. Insulet is continuing to expand its list of compatible smartphones to make this option available to as many people as possible who are living with diabetes, reports BusinessWire.

“Omnipod 5 has been such a life-changing technology. My patients and I have seen significant improvement of their time in range with no overnight lows and much less work required,” said Dr. Anita Swamy, Assistant Professor of Pediatrics, Northwestern Feinberg School of Medicine; Associate Clinician, Pediatric Endocrinology, Ann and Robert H. Lurie Children’s Hospital of Chicago; Medical Director, Chicago Children’s Diabetes Center. “It has given parents and other caregivers more peace of mind, especially overnight, and that’s priceless. People no longer have to make trade-offs between outcomes and a better lifestyle fit because it’s a tubeless AID.” She continued, “Many have told me that they have been extremely happy with Omnipod 5 and are feeling a new sense of freedom. I can see why there has been tremendous demand for this product!”

Marston Alfred, who made the switch to Omnipod 5 from multiple daily injections, said, “Having been on insulin pens for decades, I’ve had to deal with the roller coaster of blood sugar levels. Since starting Omnipod 5 as my first insulin pump, my glucose spikes have disappeared and it’s the first time in my life I’ve had weeks of consistent 80%+ time in range.”

Read more: Dexcom G6 CGM Gets Coverage in Alberta for Children and Youth Living With Diabetes

Alfred said he can’t remember the last time he had low blood sugar, and that his energy and focus have also significantly improved. “It has changed my life,” said Alfred.

Omnipod 5 and Omnipod DASH® are the only insulin pumps available through the pharmacy channel, which eliminates the high upfront cost and four-year lock-in period that is typical with the traditional Durable Medical Equipment (DME) channel, making it simpler for people with type 1 diabetes to access.

To expand awareness of Omnipod 5 as the first tubeless AID system in the U.S., Insulet has launched new direct-to-consumer TV advertising, in addition to its ongoing digital and social campaigns.

About Insulet Corporation

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle.

Biofourmis, a Boston-based global leader in virtual care and digital medicine, today announced that Intel Capital, the strategic investment arm of chipmaker Intel Corporation, has joined its Series D financing in an extension that brings the total funding raised in the round to $320M. The initial Series D funding round was announced in April and was led by global growth equity firm General Atlantic with participation by CVS Health, Trevor Fetter, and existing investors.

Biofourmis announced earlier that it is using the funds from the Series D round to scale up its virtual care offerings that drive high-quality care-at-home across the continuum as well as digital medicine initiatives, including building digital companion therapeutics to augment existing and upcoming novel therapies.

Read more: Enara Health Raises $6M to Tackle the Obesity Epidemic

"Biofourmis is laser-focused on delivering real-time patient insight to clinicians to improve the home-based care experience," said Mark Rostick, Vice President and Senior Managing Director at Intel Capital. "Through edge computing and edge-to-cloud processing capabilities, Biofourmis is redefining the patient and provider journey leveraging advanced technology."

Biofourmis continues to buck health tech funding trends with this Series D extension, which comes during a downturn in digital health investment. According to a recent Rock Health report, the first half of 2022 saw 329 digital health funding deals totaling $10.3 billion—down from $14.7 billion raised in the first half of 2021 across 372 deals, states a press release.

"To receive this additional funding from the venture capital arm of a global technology giant during an unpredictable time in digital health investment is further validation of Biofourmis' market strength and potential and validates that we are distinguishing ourselves in the market," said Kuldeep Singh Rajput, founder and CEO of Biofourmis. "We are on a strong trajectory for continued strategic growth in the coming years in terms of customers, partners, and solution development."

Biofourmis also announced the appointment of two esteemed healthcare leaders to its Board: Trevor Fetter, MBA, senior lecturer on the faculty of Harvard Business School and former longtime Tenet Healthcare Chairman and CEO; and Sachin H. Jain, MD, MBA, president and CEO of SCAN Group and SCAN Health Plan.

About Biofourmis

Biofourmis, based in Boston, is a global leader in providing advanced technology and clinical support for Care@Home and digital therapies. They are driven by a passion to personalize care and predict clinical worsening before it happens. The clinically validated platform, powered by machine learning and advanced analytics, enables better healthcare, maximizes the effectiveness of high-value drugs, and lowers costs across the entire care continuum.

ABBOTT announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to investigate the use of its deep brain stimulation (DBS) system in treatment-resistant depression (TRD), a form of major depressive disorder (MDD). Breakthrough Device Designation expedites the review of innovative technologies that can improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions.

Abbott's DBS system is a personalized, adjustable therapy that involves implanting thin wires – or leads – into targeted areas of the brain. A pulse generator implanted under the skin in the chest is connected to the leads and produces electrical impulses that can modulate abnormal brain activity. While Abbott's DBS system has traditionally been used to help control symptoms for people with movement disorders, such as Parkinson's disease and essential tremor, evidence suggests that implanting electrodes in the part of the brain that regulates mood could help reduce symptoms of TRD. Abbott is working with the FDA to develop a plan for evaluating the device's safety and effectiveness for this purpose. One of the added benefits of certain Abbott DBS systems is that they can be used with NeuroSphere™ Virtual Clinic, a first-of-its-kind connected care technology that allows people to communicate with and receive care and therapy adjustments from their doctors remotely and from the comfort of their own home, states a press release.

For patients who suffer from TRD, a condition that costs the U.S. approximately $44 billion a year in healthcare, unemployment, and lost productivity, deep brain stimulation has the potential to offer meaningful improvement of depressive symptoms. Currently, physicians have access to a range of treatments for MDD, also called clinical depression, including antidepressant medications and device therapies. Despite this, up to a third of individuals diagnosed with MDD – approximately 2.8 million Americans each year – do not respond even after trying four different antidepressant regimen approaches1,2 resulting in TRD or difficult-to-treat depression. With each failed treatment, the chance of experiencing a decrease in symptoms drops. By the fourth failed treatment, as many as 83% of patients will relapse.

Read more: Abbott, CamDiab and Ypsomed Partner Up To Develop Automated Insulin Delivery

To qualify for a Breakthrough DeviceDesignation, a device technology must address an unmet need and show that it has the potential to provide for more effective treatment of life-threatening diseases or irreversibly debilitating conditions. The goal of the program is to provide patients and clinicians with timely access to these breakthrough treatments by accelerating their development, assessment, and review while maintaining regulatory standards for pre-market approval. With Breakthrough Device Designation, Abbott's DBS system could become available as a new treatment option sooner for people affected by TRD.

"Breakthrough product development always requires bold thinking and collaboration, and Abbott is fully committed to the journey of providing people with new therapeutic options for their treatment-resistant depression," said Pedro Malha, vice president of neuromodulation, Abbott.

Abbott DBS therapy for treatment-resistant depression is limited to investigational use only.

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Their portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional, and branded generic medicines. Its 113,000 employees serve people in more than 160 countries.

Tandem's global revenues over those three months increased 16% over the same period last year, reaching a record high of a little over $200 million, but that wasn't enough to keep the diabetic technology developer on track for its 2022 objectives. The company said it will cut its full-year sales forecast to represent growth of between 19% and 20% over 2021, totaling between $835 million and $845 million, in an earnings report released Wednesday afternoon.

That represents a change in perspective from a quarter ago when Tandem adopted a far more upbeat stance by raising projections for the year's beginning. After a strong first quarter, it increased that projection to land between $850 million and $865 million, which would have represented an improvement of up to 23% over 2021's results. It started off 2022 with an eye toward total sales between $845 million and $860 million.

The San Diego-based device maker reported operating losses of over $12 million and a net loss of $15.1 million in addition to the lower-than-expected sales; these figures had been comfortably positive at this time the previous year, reports FierceBiotech. According to a copy of the call, CEO John Sheridan blamed the dip on three things: persistent "pandemic-related pressures," increasing domestic rivalry, and economic difficulties like inflation and the impending recession.

However, now that the second quarter's problems are firmly in the past, Tandem is once again upbeat, with a promising prognosis for sales of both current and emerging technology.

The Mobi insulin pump is the most prominent member of the latter group. It is roughly half as big as Tandem's top-of-the-line t:slim pump and can be entirely operated by a user's smartphone. Additionally, Sheridan stated on the call that it will be “the first novel form factor launched in our space since we introduced t:slim a decade ago,”

“We are in the final stages of testing, as well as drafting the submission, and intend to submit a 510(k) to the FDA this quarter,” the CEO said. Furthermore, he said Tandem is already making plans for the miniature pump's commercial debut after receiving FDA certification, which it hopes to do in the first half of 2023.

Read more: MFineApp Allows To Monitor Blood Pressure and Glucose

Sheridan stated that in the interim, Tandem is also closely collaborating with partners Dexcom and Abbott to integrate its insulin pumps with their most recent CGMs: Abbott's FreeStyle Libre 3, which was recently approved by the FDA, and Dexcom's G7 device, whose own FDA review is still in progress following a request for more information from the agency.

Tandem has already had a hectic year. The company's t:connect mobile app, which can be downloaded to a user's smartphone and used to remotely schedule bolus doses through the company's t:slim X2 insulin pumps, received FDA authorization at the beginning of 2022. Just a month ago, Tandem added Capillary Biomedical, a producer of extended-wear infusion set technology based in the Los Angeles region, to its portfolio. The deal's financial details weren't made public.

First Relief, a PENS (percutaneous electrical neurostimulation) device, has been cleared by the US Food and Drug Administration for multiple treatments up to 56 days for symptomatic relief of chronic, intractable pain from diabetic peripheral neuropathy, Dyansys Inc. has announced.

The wearable device placed on the ear administers continuous pulses of a low-level electrical current over several days. With the FDA clearance of First Relief, this device can be used to treat pain related to diabetic neuropathy.

Read more: Rune Labs Secures FDA Clearance

The First Relief percutaneous neurostimulation device can be used to treat pain related to diabetic neuropathy. It is applied behind the ear and delivers continuous pulses of a low-level electrical current over several days.

"We are excited to have the FDA clearance of First Relief so that this device, which has been proven effective, can now be used to treat patients who have been experiencing pain related to diabetic neuropathy," said DyAnsys CEO Srini Nageshwar. "First Relief offers a significant treatment option without drugs or narcotics."

According to a press release, the approval was based on a study that tested First Relief against a placebo and another device previously cleared by the US Food and Drug Administration. The study was conducted at the Jeevak Multispeciality Hospital in Warangal, India, renowned for the treatment of diabetes. The single-center, three-arm, randomized, controlled, parallel assignment, double-blinded, prospective study involved 63 patients aged 30 to 74.

The devices were applied on a bi-weekly basis for 16 weeks. The primary efficacy endpoint was pain intensity measured through the Visual Analog Scale (VAS) score and the secondary efficacy endpoints are vibration perception threshold (VPT) value, insomnia severity index (ISI), overall neuropathy limitations scale (ONLS), and Hamilton rating scale for anxiety.

The VAS pain score analysis showed a significant reduction in the pain score of patients being treated with First Relief from the start of the treatment to the end. This improvement persisted throughout the 90-day follow-up, suggesting that the treatment was a long-term improvement in neuropathic pain and not a short-term improvement. The secondary outcome measures (VPT, Insomnia, ONLS, and HAM) also showed similar improvements to the pain score, showing significant improvement in sleep and mood as the neuropathic pain decreased.

No complications or adverse events were observed in any of the subjects during the study period.

About DyAnsys

DyAnsys Inc. is a global company headquartered in California with subsidiaries in Switzerland and India. DyAnsys provides advanced medical diagnostic and monitoring systems to clinicians in individual practices and hospitals. DyAnsys, ANSiscope. First Relief, Primary Relief, and Drug Relief are registered trademarks, of DyAnsys, Inc.

BioCircuit Technologies, a National Institutes of Health (NIH)-founded medical device company focused on tissue repair and neuromodulation, announced today it has received FDA 510(k) clearance for its nerve repair device, Nerve Tape®. The product’s patented design is the first FDA-cleared, sutureless solution for surgical repair of transected nerves.

“The development and clearance of NerveTape represent a significant advancement in the treatment of nerve injuries,” said Jonathan Isaacs, MD, Professor and Chair, Division of Hand Surgery, Virginia Commonwealth University Medical Center. “This product has the potential to offer surgeons a faster, simpler method for achieving a precise, reliable repair of injured nerves. As a co-inventor with several years of experience using the device in animal models, I look forward to having NerveTape available for clinical use.”

“We are very pleased to have completed this critical milestone on our path towards providing a new solution for the treatment of peripheral nerve injuries,” said Michelle Jarrard, CEO ofBioCircuit Technologies. “As BioCircuit’s first FDA-cleared medical device, Nerve Tape exemplifies our commitment to equipping surgeons with powerful, practical tools to improve the treatment of injuries, and we are excited to be entering the commercial phase of development as we prepare to bring this solution to market.”  

Nerve Tape was developed in partnership with the Orthopedic Microsurgery Laboratory at Virginia Commonwealth University, Richmond, VA.

As previously announced, BioCircuit is working with supply partners in preparation for the launch of Nerve Tape in the United States. The Company anticipates the product will be available for first human use in 2023.

About BioCircuit Technologies

Based in Atlanta, GA, BioCircuitTechnologies develops and commercializes medical devices for tissue repair and neuromodulation. Designed for ease of use and reliability, these devices enhance therapeutic targeting, diagnostic precision, and surgical consistency for improved patient outcomes.

BioCircuit has received generous funding from numerous NIH grants. In addition to ongoing grant support, BioCircuit has attracted private financing, including investment from the GRA Venture Fund, Masters Capital, and Alsora Capital.

It's been a long road, but the long-standing collaboration between iRhythm and Verily, the medical sciences-focused sister company of Google, has finally arrived at its goal: The FDA has given its approval for the pair's smartwatch and software that detects an irregular heartbeat.

Verily received agency approval for its ECG-equipped Study Watch, a prescription-only wearable made to monitor participants in clinical studies, for the first time in 2019. The following year, the Alphabet division added an FDA clearance for identifying atrial fibrillation symptoms, as part of an ongoing partnership with the leader in digital heart monitoring, iRhythm, reports FierceBiotech.

The new Zio Watch, which shares the branding of iRhythm's patch-like Zio devices that cling to the chest to detect cardiac signals, is the result of the evolution of that project, according to a blog post by Verily.

While iRhythm received FDA approval for the Zio Watch's artificial intelligence-powered AFib software, called Zeus, Verily received new FDA permission for the Zio Watch itself. That nod includes a computerized arrhythmia reporting service as well as the system's algorithms. The Zio Watch with the ZEUS System is an integrated, prescription-based solution that addresses clinician workflows, care pathways, and the patient experience. The cleared Zio Watch is a wrist-worn solution that not only detects AFib but also characterizes the amount of AFib over time, thus aiding a clinician in diagnosis. The Zio Watch uses a continuous photoplethysmography (PPG), an AI-based algorithm to detect AFib and calculate an AFib burden estimate. A preliminary report is then sent to the patient's clinician for review, potentially leading to a diagnosis and clinical intervention.

Read more: Fitbit Gets US FDA Approval For Detecting AFib

“We are incredibly excited about this important milestone as we make progress in bringing a new monitoring platform to patients who can benefit from it. There is a clear need in the market today for a clinical grade, long-term and noninvasive monitoring solution,” said Quentin Blackford, CEO and President of iRhythm. “iRhythm is focused on redefining the standard of care with earlier insight to predict and prevent disease, and the Zio Watch with ZEUS System provides clinicians a platform that has the potential to meaningfully improve patients’ lives.”

“Our partnership with iRhythm advances our shared mission of delivering more efficient care for patients with AFib,” said Dr. Jessica Mega, Chief Medical and Scientific Officer and Co-founder of Verily. “The industry is ripe for a clinical grade wearable to not only improve how we monitor cardiovascular health, but also develop precision health interventions that could ultimately prevent more serious cardiac events before they can occur.”

After the FDA voiced concerns about the device's software during an assessment, diabetes tracker manufacturer Dexcom is delaying the G7, the most recent generation of its continuous glucose monitor, for release in the United States.

The company now plans to redesign how the G7 and its smartphone apps transmit alerts to inform the user of material changes in their blood sugar, despite the fact that the wearable sensor was initially submitted to the agency in late last year, reports FierceBiotech.

“We discussed several options that we had, we decided the best option at this time was to revise the software and file it differently and we have added a few other features to it as well based on our discussions with them,” CEO Kevin Sayer said on the company’s second-quarter earnings call with investors, according to a Seeking Alpha transcript.

“We are in the middle of revising the software for that, and have to run it through the complete validation and verification process and resubmit,” Sayer said. The company has narrowed expectations for the device’s initial, limited release in the U.S. to the fourth quarter, after previously planning for the FDA’s go-ahead to come at some point in the year’s second half, and has slated a full commercial rollout for early 2023.

Comparing the latest version to its mainstay G6, Sayer went on to describe how the G7’s development had already brought on a complete revamp of the company’s processes. “We changed the algorithm. We changed the insertion techniques. We changed every manufacturing procedure that we have and completely rewrote the entire app and the software experience, which is a lot for [the FDA] to digest and a lot for us to submit,” he said. “If I look at learnings for us over time, I think we will probably do things a little more incrementally going forward, rather as big as this one was, and we can get things through faster.”

Read more: People With Diabetes Who Use Dexcom G6 CGM Can Now View Their Data on Garmin Smartwatch Or Cycling Computer

The disposable G7 offers a 30-minute warmup interval after application and is around 60% smaller than its predecessor, which made its debut in 2018. This past March, it was given the all-clear in Europe, and now it is making its way to users in the U.K. A larger continental rollout will begin before the end of the year.

Following the revelation, Dexcom's stock fell by nearly 17% in after-hours trading on Thursday. However, when the Nasdaq opened on Friday, the price started to rise once more, reaching about $80 per share, or about 7% less than its previous close.

Dexcom recorded second-quarter revenue of $696.2 million, or nearly 17% more than the same period the previous year, driven by 39% sales growth in international markets. This includes revenue from the introduction of its Dexcom One programs in Spain and the United Kingdom, which are based on a more affordable, less complex system. Dexcom One, the company's first attempt to market numerous products at various price points, shares the same 10-day sensor technology as the G6 but lacks the same set of software capabilities, automated warnings, and real-time data sharing as the G6 and G7.

Even though there were speculations of a potential merger with the manufacturer of wearable insulin pumps Insulet early this year, Sayer stated in an interview last month that significant acquisitions are not on the company's top of mind despite posting $2.75 billion in cash and untapped credit.

“We’ve been the organic growth story of the decade. No medical device company goes from $40 million to almost $3 billion organically — we’ve done that,” Sayer told Fierce Medtech in an interview during the American Diabetes Association’s annual meeting. “Where we see opportunities to get technologies or capabilities that enhance what we do or possibly enable us to differentiate in the future, we will consider that,” he added, perhaps coming from small startups outside its main product line that the company has already invested in, as well as from the purchase of existing distribution partners to help increase its geographic footprints.

Today, Cognito Therapeutics announced that its proprietary gamma sensory stimulation at 40Hz over a 6-month period reduced white matter atrophy in the brain for patients with Alzheimer’s Disease, according to new data presented at the Alzheimer’s Association International Conference 2022.

Alzheimer’s Disease (AD) is the most common form of dementia. Although white matter atrophy is observed in normal aging, it is more pronounced in AD patients. White matter degeneration, myelin loss, and oligodendrocyte damage in AD patients suggest that white matter can be a mechanistically important target for AD.

The data presented from the OVERTURE study and the Alzheimer’s Disease Neuroimaging Initiative (ADNI1) database, suggest that Cognito’s 40 Hz gamma sensory stimulation therapy for a 6-month period may reduce white matter atrophy, protect axons, and possibly prevent myeline and oligodendrocyte damage in AD patients. Given the crucial role of white matter connecting expansive brain regions, preventing or reducing its atrophy may diminish AD disease progression, reports BusinessWire.

The OVERTURE study treatment group participants received 1 hour of Cognito’s daily 40Hz simultaneous auditory-visual sensory stimulation at home for a 6-month period with placebo group participants receiving sham stimulation. Analysis between the groups suggested a difference in white matter atrophy favoring the treatment group. To compare the treatment group with a larger control group, Cognito studied ADNI1 data as well.

The OVERTURE study treatment group participants exhibited a 0.38±0.82 percentage increase and ADNI1 study participants exhibited a -2.45±0.40 percentage decrease in white matter volume after a 6-month period (p<0.004).

Cognito also presented OVERTURE study results at an AAIC Featured Research Session titled: Neuronal excitation/inhibition imbalance contributes to Alzheimer’s disease pathology and represents a potential target for treatment. Summary results of OVERTURE clinical trial demonstrated that gamma sensory stimulation is safe and well tolerated, and efficacy outcomes indicated beneficial clinical effects, including maintained cognitive and functional abilities, reduced brain atrophy, and improved sleep quality.

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“Our proprietary gamma sensory stimulation therapy for a 6-month period was shown to reduce white matter atrophy, and potentially protect axons, prevent myelin, and oligodendrocyte damage in Alzheimer’s patients,” said Brent Vaughan, Chief Executive Officer, Cognito Therapeutics. “These results continue to build on our knowledge and understanding of how gamma frequency patterns in the brain are disrupted in patients with Alzheimer’s Disease, and how our technology restores the levels of neural activity to improve cognition.”

“Given the crucial role of white matter connecting expansive brain regions, preventing or reducing its atrophy may diminish disease progression. These results presented at AAIC indicate that our therapy can potentially improve outcomes for patients with Alzheimer’s and Mild Cognitive Impairment, as well as other neurodegenerative diseases that involve loss of white matter and myelination,” added Mihaly Hajos, Ph.D., Chief Scientific Officer, Cognito Therapeutics.

About Cognito Therapeutics

Cognito Therapeutics is a pioneer in disease-modifying therapeutic interventions for neurodegenerative diseases and human cognitive performance. The company has completed multiple clinical studies demonstrating its investigational therapeutic platform has the potential to safely slow or stop the cognitive decline and loss of brain volume in Alzheimer’s disease. Cognito has received FDA Breakthrough Device Designation for treatment of the cognitive and functional symptoms associated with Alzheimer's disease in individuals diagnosed with mild to moderate Alzheimer’s and expects to start pivotal studies in 2022. The company’s technology is based on pioneering optogenetics research by scientific co-founders Professors Li-Huei Tsai and optogenetics pioneer Ed Boyden at MIT. Cognito Therapeutics is based in Cambridge, MA.

Three-year-old twins in Brazil who were conjoined at the head have been successfully separated with the help of virtual reality. Twins Bernardo and Arthur Lima underwent surgeries in Rio de Janeiro with support and direction from Great Ormond Street Hospital in London.

Described by Noor ul Owase Jeelani, a surgeon, as “space-age stuff,” the teams spent months trialing techniques using virtual reality projections of the twins, based on CT and MRI scans.

Read more: UK Virtual Reality Startup Moonhub Launches VR Dementia Training Suite

After experts told the twins’ medical team in Rio de Janeiro that a separation surgery was impossible, they turned to Gemini Untwined and its founder, Noor Ul Owase Jeelani, M.B.B.S., who was able to work with the team at Rio’s Instituto Estadual do Cérebro Paulo Niemeyer to successfully complete the procedure.

The twins were born in 2018 in the state of Roraima, northern Brazil, as craniopagus twins – an extremely rare condition in which the siblings are fused at the cranium – and have spent most of their lives in a hospital in Rio de Janeiro, reports EuroNews.

“We had been living in the hospital for four years,” the boys’ mother, Adriely Lima, said in tears after the separation. The operation was carried out in Rio de Janeiro with direction from Great Ormond Street Hospital in London.

The planning stage took place over a six-month period which, led by UK surgeon Dr. Noor ul Owase Jeelani, incorporated models of the twins based on CT and MRI scans which were imported into a program that allowed the Brazilian and UK teams to collaborate in real-time via VR headsets.

Now, after seven surgeries, the boys have effectively become the oldest craniopagus twins to have been separated, a process which concluded in a final surgery that lasted 27 hours and involved around 100 medical staff.

“Not only have we provided a new future for the boys and their family, but we have also equipped the local team with the capabilities and confidence to undertake such complex work successfully again in the future,” said Jeelani.

On September 9, 2022, in San Diego at the AHA Hypertension Sessions, Aktiia presented the results of an analysis co-authored by experts from Barts NIHR Biomedical Research Centre (London, UK), Scripps Translational Research Institute (La Jolla, USA), Lausanne University Hospital (Lausanne, CH), Brigham and Women’s Hospital (Boston, USA), and Mayo Clinic (Phoenix, USA) demonstrating that hypertensive patients who monitor their blood pressure (BP) with Aktiia’s 24/7 BP monitor achieve a significant and sustained reduction in systolic BP. Aktiia’s optical continual BP monitor has been available for purchase in seven European countries since March 2021. By design and purpose, Aktiia’s passive and continual collection of BP data has quickly compiled over 55,000,000 data points in real-world conditions, establishing the largest dataset of BP readings in the world which uniquely enables Aktiia and its partners to unlock new insights into hypertension.

The objective of Aktiia’s recent investigation was to explore whether a change in behaviour resulting in measurably lower BP would be demonstrated in hypertensive subjects who were consistently exposed to their BP data via Aktiia’s integrated mobile app. The analysis concluded that mean SBP was reduced in -3.2 mmHg (confidence interval: [-0.70, -5.59], p<0.02) for hypertensive users (SBP > 140 mmHg) following 3 months of continual cuffless BP monitoring (Figure 2). This reduction was then sustained throughout the 6 months studied. Mean SBP remained unchanged for normotensive users (SBP < 140 mm Hg).

The powerful relationship between BP reduction and reduction of cardiovascular events is undisputed, irrespective of the mechanism for the reduction. Even a 5 mm Hg reduction in systolic BP reduces cardiovascular risk by 10%. By using Aktiia consistently, people were not only made aware of their condition but were empowered to make changes to their behaviour which achieved an effect similar to that of a medication. Aktiia will continue to expand research that investigates the factors contributing to this reduction in blood pressure, and work to augment these benefits among the Aktiia user population. These data highlight just the beginning of the tremendous value of Aktiia’s dataset across the hypertension care continuum.

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Rockley Photonics Holdings, a global leader in photonics-based health monitoring and communications solutions, announced that it has signed a supply agreement outlining the customer’s initial purchase commitment for 2023 and received the first commercial purchase order for its non-invasive biomarker sensing wristbands from a global healthcare technology provider. The Bioptx™ Baseline devices included in this order will employ Rockley’s biosensing technology, a complete end-to-end solution that enables the non-invasive, continuous, and near-real-time monitoring of multiple biomarkers. The initial units are expected to ship in Q4 2022, which could put Rockley’s ground-breaking biosensing technology on the wrists of end-users by the end of 2022.

Read more: iRhythm Receives FDA Clearance for its ZEUS System

The Rockley Bioptx band represents a new class of wearable biosensing devices, with enhanced health monitoring capabilities and a flexible design that’s appropriate for a multitude of applications and uses, such as professional healthcare or general health and wellness. The form and function of the device allow it to be worn on the wrist or other locations on the body, depending on the use case and physical requirements. In addition to a versatile form factor, the Bioptx band features a flexible hardware design that will support a range of software stacks that can be customized to address the specific needs of various customers. The software can be further adjusted to optimize battery life for extended use or maximize performance for intensive duty cycles, says a press release.

Dr. Andrew Rickman, chairman and chief executive officer of Rockley, said, “This is a pivotal moment for Rockley as our MedTech customers begin to deploy wearable, non-invasive biosensing solutions that could help improve patient treatment. To support the demand, we have established manufacturing partnerships to provide high-volume production, which is planned for 2023. This initial order, along with the commitment for future orders, represents a significant step toward expanding our ‘Powered by Rockley’ presence in the MedTech market — and brings us closer to our goal of empowering people with timely insights and fostering a more personalized approach to managing health and well-being.”

Rockley's photonics-based biomarker sensing platform miniaturizes the capabilities of lab-based spectrometers onto a single wrist-worn device, enabling a new class of wearable health monitoring solutions. Rockley has conducted several human studies designed to validate the performance of its solution. The results of these ongoing studies continue to help enhance functionality and will support the delivery of non-invasive biosensing products to customers. Rockley expects to work with its partners and customers toward receiving clearance for Rockley-powered wearable devices from the U.S. Food and Drug Administration (FDA) and other regulatory agencies.

About Rockley Photonics

A global leader in photonics-based health monitoring and communications solutions, Rockley Photonics is developing a comprehensive range of photonic integrated circuits and associated modules, sensors, and full-stack solutions. From next-generation sensing platforms specifically designed for mobile health monitoring and machine vision to high-speed, high-volume solutions for data communications, Rockley is laying the foundation for a new generation of applications across multiple industries. Rockley believes that photonics will eventually become as pervasive as micro-electronics, and it has developed a platform with the power and flexibility needed to address both mass markets and a wide variety of vertical applications.

Formed in 2013, Rockley is uniquely positioned to support hyper-scale manufacturing and address a multitude of high-volume markets. Rockley has partnered with numerous tier-1 customers across a diverse range of industries to deliver complex optical systems required to bring transformational products to market.

SyncThink, a next-generation neurotechnology company, and makers of the award-winning EYE-SYNC technology, announces today that it has completed CE Mark certification, affirming conformity to European Medical Device Regulation (MDR), also known as ISO13485. EYE-SYNC will be registered as a Class I medical device.

“The CE Mark authorization for EYE-SYNC is a tremendous advancement in our commitment to bringing objective, reliable measures of neurological function to healthcare providers in Europe,” said SyncThink Chairman and CEO Gary Gregory. “We are excited to expand our commercial opportunities and strengthen our position in the market while making our product more accessible to patients everywhere.”

The new certification allows for the commercialization of EYE-SYNC in the European Union (EU) and the United Kingdom (UK), expanding opportunities for new business development and distribution in applicable nations. Providers in these areas will be able to purchase and implement the EYE-SYNC system beginning this month, utilizing the most recent version of EYE-SYNC that comes equipped with PicoXR’s Neo 3 Pro Eye, the company said in a press release.

The CE Mark is the latest advancement among a series of growth announcements for the company. In addition to the PicoXR partnership, SyncThink recently announced the expansion of its clinical advisory board, shortly after receiving its second FDA clearance for EYE-SYNC as an Aid to Concussion Diagnosis or mild Traumatic Brain injury (mTBI). Earlier this year, SyncThink was selected by Augmented Reality (AR) leader Magic Leap as a partner in their efforts to expand into healthcare worldwide.

The EYE-SYNC technology combines proprietary software and data analytics with high-performance eye-tracking sensors to measure and quantify eye movement biomarkers reflective of neurological impairment or disease. It is currently used by healthcare providers in hospitals and rehabilitation centers, sports, the military, and in CNS drug development around the world.

Read more: Wise Therapeutics and Soterix Announce Results of Their Collaborative Study Combining Digital Therapy With Neurostimulation Device

The Conformitè Europëenne (CE) Mark. confirms the manufacturer’s goods conform with European health, safety, and environmental protection standards. It is defined as the European Union’s (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985. The CE marking represents a manufacturer’s declaration that products comply with the EU’s New Approach Directives. These directives not only apply to products within the EU but also to products that are manufactured in or designed to be sold in the EEA. This makes the CE marking recognizable worldwide even to those unfamiliar with the EEA.

About SyncThink

SyncThink is on a mission to provide objective neurological measurements that assist medical professionals in assessing brain health, delivering therapies, and optimizing performance. SyncThink develops revolutionary eye-tracking software and analytic technologies, delivered in a rapid, accurate, and easy-to-use XR platform. With more than 30 published peer-reviewed papers and 15 granted patents, the SyncThink platform uses a series of 60-second assessments to objectively measure eye movements to identify impairments and offers multiple modalities to improve dynamic vision. FDA-cleared for detecting eye-tracking impairments and as an aid to concussion diagnosis, EYE-SYNC is used by leading medical centers such as Stanford and Massachusetts General, the U.S. military, and more than 20 top universities, SyncThink is transforming neurological assessment, recovery, and performance for health and sport.

NICE, the National Institute for Health and Care Excellence, is currently evaluating PDMonitor, a continuous monitoring system for people with Parkinson’s disease created by medical device company PD Neurotechnology, for use on the NHS.

The August 31 meeting of the NICE special committee is the first step towards establishing guidelines for - and ultimately driving clinical uptake of - these technologies, which include: the Personal KinetiGraph (PKG) movement recording system from Global Kinetics; the Kinesia 360, and KinesiaU from Great Lakes Neurotechnologies; the PDMonitor from PD Neurotechnology; and STAT-ON from Sense4Care. KinesiaU is pending CE marking, while the remaining four are already CE-marked.

Expanding patient review options

The assessment will evaluate whether such remote continuous monitoring devices are effective and reliable for monitoring motor symptoms, tremors, and sleep disturbance that could indicate if the patient is deteriorating or not. Assessing movement at night may also help identify sleep-related issues such as interrupted sleep which could be caused by symptoms returning when medications wear off or nocturia.

Read more: Ava: AI-Powered Digital Assistant for Seniors Developed by 100Plus

The data collected could potentially be used by clinicians to manage symptoms during, in between, and sometimes in place of, in-office review appointments, according to NICE.

These five technologies generally comprise a wearable (though the number of devices and place where they are worn would vary from one system to another) and associated software and management app. Only products capable of generating results with no input, or limited input, from the user have been included in this assessment, reports FirstWord HealthTech.

“Parkinson’s is the world’s second most common neurodegenerative disease and a significant cause of disability. Patient's quality of life and disease progression strongly depend on the consistent, prompt staging of the disease and optimal timing as well as dosing of the prescribed therapy," said Professor Ray Chaudhuri, head of Parkinson's research at King's College Hospital, who has been piloting PDMonitor with private patients since March 2022.

“PDMonitor is supporting a paradigm shift in Parkinson’s care by improving the quality and timeliness of information physicians have to assess the disease. Monitoring patients at home, continuously while they conduct everyday activities, allows treatment decisions to be made more frequently and physicians to respond faster to changing symptoms. While you cannot reverse Parkinson’s, you can delay the deterioration of symptoms and possibly decrease the risk of falling. Optimizing care means the disease progresses slower in time and the therapeutic window is kept open.”

Ellipsis Health, the market leader in AI-generated voice biomarker technology, and Ceras Health, a leader in digital health solutions, announced a partnership that will integrate Ellipsis Health's breakthrough technology that uses the human voice as a biomarker for mental health and well-being into Ceras' clinical monitoring platform. This integration will combine Ellipsis Health's AI and deep learning technology with Ceras Health's clinical monitoring and health data analytics platform, enabling real-time severity scores for anxiety and depression to improve care and triage patients in need.

Currently, mental health conditions are at epidemic proportions. In the US, 28 percent of people have depression, while 36 percent suffer from anxiety, and 41 percent reported mental health disorders within the last year, two times more than in 2019. The National Alliance on Mental Health estimates that 55 percent of people with mental illness are not receiving treatment, and there is a projected shortage of up to 30,000 psychiatrists in the US by 2024. This explosive growth, coupled with the difficulty in accessing the right treatment for many populations, is part of the impetus for the Ellipsis Health and Ceras Health partnership. Together, the companies plan to bring greater access to mental health treatment for the more than 18 million Medicare patients who have mental health conditions, according to a press release.

"This new partnership will advance the state of mental health care, enabling Ellipsis Health to put its cutting-edge voice technology to work - identifying people in need and then connecting them into integrated behavioral health services," said Mainul Mondal, founder and CEO of Ellipsis Health. "We are proud to partner with Ceras Health, an organization that shares our commitment to using innovative technology to ensure that those in need have access to the right care at the right time, with the potential to transform how mental healthcare is identified, monitored, and delivered."

Bringing technology-powered innovation to mental health care, Ellipsis Health is giving voice to a new standard of care, pioneering the only clinically validated vital sign for mental health. By harnessing the unique power of the human voice as a biomarker for mental well-being, along with machine learning and AI, Ellipsis Health identifies, measures, and monitors the severity of stress, anxiety, and depression at scale. Its technology analyzes a short voice sample to create an objective and scalable clinical decision support tool.

Read more: Fujitsu and Salesforce Team Up on Healthcare Solutions

"This unique partnership with Ellipsis Health aligns with Ceras Health's commitment to providing impactful care for our patients with chronic diseases and innovating how we deliver this care," said Udaya Devineni, Chief Executive Officer (CEO) of Ceras. "The ability to access mental healthcare has never been more important given these unprecedented times, especially for those patients who are also managing chronic diseases, and we are excited about the potential of providing patients with easy and direct access to mental health support."

Ceras Health will be using Ellipsis Health's technology in its digital transitions of care solutions which are transforming how healthcare is delivered, especially for Medicare and other vulnerable populations. By using a combination of 24/7 clinical expertise, remote patient monitoring, artificial intelligence (AI), and advanced data analytics, Ceras Health's solutions blend clinical expertise and digital tools to help patients get the whole person personalized care they need to drive improvements in their health outcomes.

About Ellipsis Health

Ellipsis Health was founded with the belief that a person's mental health should have the same priority as one's physical health. The company saw an opportunity to connect the dots between the two - giving voice to a new standard of mental health care. By harnessing the unique power of the human voice as a biomarker for mental well-being, along with machine learning and AI, Ellipsis Health has established the only clinically validated vital sign for mental health. Its technology identifies, measures, and monitors the severity of stress, anxiety, and depression at scale by analyzing a short voice sample to create an objective and scalable clinical decision support tool. Through partnerships with providers, payers, employers, and digital health companies, Ellipsis Health is working to positively impact the quality of care, shorten the time to diagnosis, drive workflow efficiencies, reduce costs, and improve patient outcomes.

About Ceras Health

Ceras Health is a pioneering digital health solutions provider, utilizing 24/7 clinical expertise and remote monitoring, advanced AI and analytics, connected health devices, and personalized behavioral change, as well as a gamification platform to help and empower patients through their transitions of care. Ceras partners with health systems, providers, and payers, to deliver solutions to vulnerable populations to improve their health outcomes and care experience through digital care with a human touch.

Innovative Eyewear, a developer and retailer of cutting-edge eyeglasses and sunglasses designed to allow users to remain connected to their digital lives, announced the pricing of its initial public offering of 980,000 units consisting of 980,000 shares of its common stock and two accompanying warrants to purchase up to 1,960,000 shares of common stock. Each share of common stock is being sold together with two warrants, each to purchase one share of common stock with an exercise price of$7.50 per share at a combined offering price of $7.50, for gross proceeds of approximately $7.35 million, before deducting underwriting discounts and offering expenses. In addition, Innovative Eyewear has granted the underwriters a 45-day option to purchase up to an additional 147,000 shares of common stock and/or warrants to purchase up to 294,000 shares of common stock to cover over-allotments at the initial public offering price, less the underwriting discount. The company offers all of the shares of common stock and warrants.

The shares of common stock and warrants are expected to begin trading on the Nasdaq Capital Market on August 15, 2022, under the symbols "LUCY" and "LUCYW," respectively. The offering is expected to close on August 17, 2022, subject to satisfaction of customary closing conditions, says a press release.

The company intends to use substantially all of the net proceeds from the offering for advancing its sales and marketing, expanding inventory, updating and producing in-store displays, developing new styles and sizes of the company's smart eyewear, and for working capital and other general corporate purposes.

Maxim Group LLC is acting as the sole book-running manager in connection with the offering.

A registration statement on Form S-1 (file no. 333-261616) was filed with the Securities and Exchange Commission("SEC"), which became effective on August 12, 2022. A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website at http://www.sec.gov. The offering is being made only by means of a prospectus forming part of the effective registration statement. Electronic copies of the prospectus relating to this offering, when available, may be obtained from Maxim Group LLC, 300 Park Avenue, 16th Floor, New York, New York 10022, at (212) 895-3745. Before investing in this offering, interested parties should read in its entirety the registration statement that the company has filed with the SEC, which provides additional information about the company and this offering.

Read more: Enara Health Raises $6M to Tackle the Obesity Epidemic

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Innovative Eyewear, Inc.

Innovative Eyewear is a developer and retailer of smart eyewear, which are designed to allow users to remain connected to their digital lives, while also offering prescription eyewear and sun protection. The company believes that traditional frames, no matter how attractive, do not possess the functionality that many eyeglass wearers need and want. Smart eyewear is a multifunctional product that addresses the needs of the optical, wearables, and digital assistant markets. We believe that the company's products are well positioned in this rapidly growing wearables ecosystem, with the mission to Upgrade Your Eyewear®.