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.

Read more: Neurable’s New Headphones Use Artificial Intelligence To Help You Focus

“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®.

Our Innovation of the Month takes care of the most valuable gift we have: Kids!

Oopsie Heroes is a fun and simple bedwetting alarm for kids. It combines an app with a tiny sensor that teaches children how to make it to the toilet on time at night. The sensor is super simple to use and can be easily fastened to all undergarments and pj’s - no special clothing required. Also, instead of Bluetooth, the Oopsie sensor uses a simple sound to send the information to the app. Goodbye Oopsie moments!

About the Lifesense Group:

LifeSense Group is a global B2B company based in Eindhoven, the Netherlands that designs and makes digital health continence solutions. Their international team draws on their breadth of knowledge, expertise, and experiences to continually bring forth new products and applications which can revolutionize the market of digital health continence solutions.

Since its establishment, LifeSense Group has developed, launched, and certified four award-winning digital health continence solutions for the whole family. It is their mission to empower families every day with their technology. LifeSense Group products include Carin (women), Wil (men), Oopsie Heroes (children), as well as Plan Be (healthcare providers). These patented innovations have undergone clinical pilot trials and are reimbursed by health insurers in the Netherlands, Sweden, Taiwan, and Australia.

ŌURA, the company behind the smart ring that delivers personalized health data, insights, and daily guidance, and Natural Cycles, the first FDA-cleared birth control app, announced their partnership. Natural Cycles users will now be able to sync temperature trend data straight from the Oura Ring, allowing them to track their temperature trends automatically while they sleep rather than manually taking their temperature with an oral thermometer when they wake up.

Natural Cycles works by analyzing established hormone-driven temperature patterns, along with other key fertility indicators, to determine red (fertile) or green (not fertile) days to plan or prevent pregnancy naturally. Previously, Natural Cycles could only obtain temperature data by users manually taking their temperature each morning, says a press release.

“We have been actively working on delivering a seamless measuring experience for our users and we were thrilled when we received FDA clearance to use the Oura Ring with our algorithm,” said Natural Cycles co-founder and CEO Dr. Elina Berglund Scherwitzl. “We are proud to officially launch this partnership and work alongside a company that is similarly committed to delivering advanced health tools to women at a time when it has never been more important. With the help of Oura data, Natural Cycles is powering the future of birth control.”

Reproductive health has historically been underserved by medicine, science, and tech, but thanks to companies such as Natural Cycles and ŌURA, science has taken monumental steps forward in recent years. In 2018, the FDA cleared Natural Cycles as the first contraceptive app, making birth control history. Now, the company has moved one step further by utilizing temperature trend data from the Oura Ring, providing women with an innovative and effortless experience to plan or prevent pregnancy without hormones.

Read more: Apple Reportedly Looking to Add Blood Pressure Monitoring and Fertility Tracking In Smartwatch

The temperature sensors in the Oura Ring generate 1,440 data points each day and are validated to measure temperature changes as precisely as 0.13°C (0.23°F). In addition to temperature trend data, the Natural Cycles algorithm uses heart rate data from the Oura Ring to take into account nights with elevated heart rates, and hence also temperatures, that may be due to lifestyle changes, such as high alcohol consumption, rather than due to menstrual cycle changes.

“Partnering with Natural Cycles is a natural fit given our research has shown that skin temperature data from the Oura Ring can detect important temperature changes throughout the menstrual cycle, including increases around the LH surge, which occurs just before ovulation, and decreases nearing menstruation,” said Holly Shelton, Senior Vice President of Consumer Product at ŌURA. “The partnership between Natural Cycles and Oura shows the power of technology to enable women to better understand and take control of their fertility.”

Beyond cycle insights, the Oura Ring tracks and analyzes sleep quality based on the body’s key vitals and time spent in each sleep stage. During the day, members can utilize the Daytime Heart Rate, Workout Heart Rate, and Automatic Activity Detection features to evaluate their movement and restorative time. These personalized health metrics are then summarized into Sleep, Activity, and Readiness Scores, which are displayed alongside insights and personalized guidance that help provide a holistic view of health.

Natural Cycles users with an Oura Ring can begin syncing their ŌURA data once they switch to ŌURA Mode within the Natural Cycles app. If an Oura user gives explicit consent, ŌURA will only share sleep data with Natural Cycles, which includes temperature trends, HR, sleep length, and sleep stages. The partnership is a one-way integration, and Natural Cycles does not share any sensitive data with ŌURA.

About ŌURA Health

ŌURA is the company behind the Oura Ring - the smart ring that delivers personalized health data, insights, and daily guidance. ŌURA believes health is a daily practice and, with personalized insights and guidance, you can control the course of your health to live a more balanced life. The ring tracks all stages of sleep as well as recovery and accounts for daily activity to provide practical steps for long-term improvement. Founded in 2013, ŌURA Health is headquartered in Oulu, Finland, with offices in Helsinki, San Francisco, and San Diego. ŌURA has raised capital in the past from Lifeline Ventures, Forerunner Ventures, Temasek, The Chernin Group, JAZZ Venture Partners, and MSD Capital, among others.

About Natural Cycles°

Natural Cycles° is a leading women’s health company that developed the world’s first birth control app, which has been used by millions of women around the world. As a Class II medical device, the NC°app is cleared by the FDA in the United States and certified to be used as a contraceptive in Europe, Australia, and Singapore. It has also received regulatory clearances to integrate with third-party wearables. For a monthly or annual subscription fee, users have access to and can switch between NC° Birth Control, NC° Plan Pregnancy, and NC° Follow Pregnancy modes within the app. NC°Birth Control’s clinical effectiveness and real-life effectiveness are proven to be 93% effective with typical use and 98% effective with perfect use. Founded in 2013 by Physicists Dr. Elina Berglund and Dr. Raoul Scherwitzl, Natural Cycles° is committed to pioneering women’s health with research and passion. The company’s on-staff research team has contributed to 14 peer-reviewed research papers.

Alimetry, a medical device and digital healthcare company, based in Auckland, received US Food and Drug Administration(FDA) clearance for Gastric Alimetry, a pioneering non-invasive medical device for aiding the diagnosis of gastric disorders. Alimetry also announced today the launch of Alimetry Inc., a subsidiary based in Minneapolis, MN, that will market and distribute Gastric Alimetry in the United States, according to a press release.

“Gastric Alimetry is an industry-first and genuine breakthrough in gut diagnostics,” said CEO Greg O’Grady, a Professor of Surgery and co-founder of Alimetry. “Alimetry’s unique technology harnesses the power of stretchable electronics, wearables, digital health, and cloud-based analytics to deliver a completely non-invasive solution. We are thrilled to announce FDA’s clearance of Gastric Alimetry, making this new test available to millions of Americans suffering from chronic gastric symptoms”.  

The Gastric Alimetry test is performed in a clinical setting. Recordings are taken before and after a meal, while patients simultaneously log their symptoms into the Gastric Alimetry App. The system performs a high-resolution recording of digestive patterns from the skin surface and delivers clinical reports via the cloud to inform the diagnosis of gastric diseases and support personalized therapy.  

Read more: Fitbit Gets US FDA Approval For Detecting AFib

The system is indicated for common stomach disorders including nausea and vomiting, gastroparesis, and functional dyspepsia, affecting over 8% of the world’s population, and costing billions of dollars in healthcare expenses. The test is also currently available in the United Kingdom and New Zealand.  

“Diagnosing gastric symptoms has been a deeply challenging clinical problem,” Dr. O’Grady said. “Existing tests are frequently unreliable and inconclusive, and patients may undergo months or even years of testing - often costly, invasive, or involving radiation - only to end in confusion and trial-and-error care. Gastric Alimetry is a game-changing tool that will bring improved clarity to the field, enabling enhanced clinical outcomes, and safer, more accessible, and less-invasive care.”

Gastric Alimetry is the result of a decade of world-leading science and innovation by an interdisciplinary team of clinicians, engineers, designers, and scientists. “FDA clearance of Gastric Alimetry cements Alimetry’s path to leadership in gastrointestinal wearables and non-invasive diagnostics,” Dr. O’Grady said. “Alimetry has an outstanding pipeline of innovation and this is the first plank in a series of innovative new features and products that stand to transform care in disorders of gastrointestinal function”. Gastric Alimetry will be available commercially from July 2023.

About Alimetry

Alimetry was spun-out of the University of Auckland in 2019 from a center of excellence in digestive diseases. The company was founded by Professor Gregory O’Grady, a gastrointestinal surgeon, and Dr. Armen Gharibans, on the background of a decade of award-winning science.

Today iRhythm Technologies, a leading digital healthcare solutions company focused on the advancement of cardiac care, announced it received FDA 510(k) clearance for its ZEUS (Zio ECG Utilization Software) System for the Zio Watch. Produced in partnership with Verily, an Alphabet precision health company, the ZEUS System combines deep learning algorithms with a proven and trusted cardiac arrhythmia service. The ZEUS System is the AI algorithm and solution component of the Zio® Watch: a sensor-based wearable for the noninvasive, clinical grade, long-term continuous monitoring of atrial fibrillation (AFib). Verily also received FDA 510(k) clearance for the Zio Watch (Study Watch with Irregular Pulse Monitor).

Read more: Fitbit Gets US FDA Approval For Detecting AFib

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 interventions, according to a press release.

“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 intervention that could ultimately prevent more serious cardiac events before they can occur.”

iRhythm has what is believed to be the world’s largest repository of labeled ECG data, which it leveraged to develop its proprietary PPG algorithm. Findings from the Verily Study: Watch AFib Detection At Home, revealed at HRS, show that interval-level sensitivity and specificity of the AFib Context Engine (ACE) algorithm within the ZEUS System were 93.6% and 99.1% respectively. Zio XT was used as a reference for computing performance. AFib episodes occurred in 30.4% of subjects, and the median AFib burden was 9.3%. The Zio Watch PPG-derived AFib burden estimate was an accurate measure when compared to the Zio XT reference. iRhythm's proprietary ACE algorithm utilizes a novel convolutional neural network architecture designed to operate on a cloud-enabled system compatible with a battery-constrained device. The results of ACE are presented in clinical preliminary reports summarizing AFib presence over the monitoring period. This process enables clinicians to receive clinically meaningful data on AFib presence/absence, rather than just a single data point in time.

“We’re proud to introduce a clinical-grade wearable that has the potential to fill an important gap in patient care by enabling the early detection and long-term monitoring of atrial fibrillation,” said Mark Day, Chief Technology Officer at iRhythm. “This technology is fundamental to growing a disruptive new monitoring platform for iRhythm.”

The Zio Watch will be complementary to Zio monitors by adding a modality with longer wear times for patients who require long-term monitoring in order to detect, characterize, and manage AFib. The Zio Watch is designed to be a cost-effective, noninvasive monitoring solution, and will fully integrate with the Zio service. iRhythm plans to introduce the ZEUS System for a limited market evaluation in 2023.

Disclaimer: The Zio Watch and the ZEUS System are not yet commercially available at this time and iRhythm will continue to build clinical research going into 2023.

About iRhythm Technologies, Inc.

iRhythm is a leading digital healthcare company redefining the way cardiac arrhythmias are clinically diagnosed. The company combines wearable biosensor devices worn for up to 14 days and cloud-based data analytics with powerful proprietary algorithms that distill data from millions of heartbeats into clinically actionable information. The company believes improvements in arrhythmia detection and characterization have the potential to change the clinical management of patients.

About Verily

Verily is a subsidiary of Alphabet that is using a data-driven, people-first approach to change the way people manage their health and the way healthcare is delivered. Launched from Google X in 2015, Verily’s purpose is to bring the promise of precision health to everyone - every day. Verily is focused on generating and activating data from a wide variety of sources, including clinical, social, behavioral, and the real world, to arrive at the best solutions for a person based on a comprehensive view of the evidence. Verily uses its recognized expertise and capabilities in technology, data science, and healthcare to enable the entire healthcare ecosystem to drive better health outcomes.

InnovationLab, an expert in printed electronics "from lab to fab", announced its breakthrough in additive manufacturing of printed circuit boards (PCBs), helping to meet higher environmental standards for electronics production while also reducing costs.

Within the research project SmartEEs2, funded by Horizon 2020, InnovationLab and its partner ISRA have developed a novel manufacturing process for copper-based solderable circuits. The circuits are screen printed and are compatible with conventional reflow processes.

Read more: New Capacitor Could Enable Energy-Efficient Microchips

Producing printed electronics is an additive process that does not use toxic etchants, and runs at comparatively low temperatures of around 150oC, thus reducing energy consumption. Moreover, the substrates used in additive PCB manufacturing are up to 15 times thinner, compared to conventional techniques, which reduces material consumption and waste during the production process. For further information, see the IDTechEx report on 3D Electronics/Additive Electronics 2022-2032.

InnovationLab has so far produced a physical prototype, which includes all the important blocks of a smart label. It uses copper ink to ensure high conductivity. Component mounting can be done in a conventional reflow soldering process, which enables manufacturers to switch to the new technology without investing in new equipment.

Multilayer layer printing -metal and dielectric - was used to produce the target functionality: a low power temperature sensor and logger, an NFC communication interface via a printed antenna, and a compact battery that is charged from a printed solar cell, making the device completely self-sufficient. The new process can produce both standard and flexible PCBs with up to four layers and can be used in product and process development for hybrid electronics.

Dr. Janusz Schinke, Head of Printed Electronics at InnovationLab, said, "This is a state-of-the-art production process, which will decrease costs and reduce logistical dependencies on suppliers while delivering three key benefits for the environment: consuming fewer materials, using less energy, and producing less waste. By the end of this year, we expect to have scaled this process to high volumes, meeting customer demands of a million solderable tracks or more."

SmartEEs2 is a European project, which is funded by the European Union's Horizon 2020 research and innovation program. Its objective is to provide acceleration support to innovative companies for the integration of flexible and wearable electronics technologies, and thus help the European industry's competitiveness.

About InnovationLab

Founded in 2008, InnovationLab GmbH is a one-stop shop for printed electronics, with a focus on flexible pressure sensors, as well as temperature, moisture, and gas sensors, and the capability to design and produce fully integrated hardware/software systems. The company offers highly customized solutions and supports high-volume production at two manufacturing sites in Germany, providing hands-on support to its customers throughout the entire product value chain, from concept to bulk production of printed functional products. InnovationLab provides state-of-the-art infrastructure along with comprehensive expertise in materials, processes, and printing technologies to develop novel products. InnovationLab also supports numerous research and industrial partners at its lab and fabrication facility, an interdisciplinary environment featuring 6200 m2 of usable space for production, development, and offices, including 700 m2 of state-of-the-art cleanrooms.

A pioneering project, which aims to develop advanced sensors for usage in robotic systems, could transform prosthetics and robotic limbs. The research project is led by the University of the West of Scotland (UWS), Integrated Graphene Ltd, and supported by the Scottish Research Partnership in Engineering (SRPe) as well as the National Manufacturing Institute for Scotland (NMIS) Industry Doctorate Programme in Advanced Manufacturing. It aims to develop sensors that provide enhanced capabilities to robots, helping improve their dexterity and motor skills, through the use of accurate pressure sensors which provide haptic feedback and distributed touch.

Read more: UC Berkeley Engineers Develop New Technique for Making Wearable Sensors

Professor Des Gibson, Director of the Institute of Thin Films, Sensors, and Imaging at UWS and project principal investigator, said: "Over recent years the advancements in the robotics industry have been remarkable, however, due to a lack of sensory capabilities, robotic systems often fail to execute certain tasks easily. For robots to reach their full potential, accurate pressure sensors, capable of providing greater tactile ability, are required. Our collaboration with Integrated Graphene Ltd, has led to the development of advanced pressure sensor technology, which could help transform robotic systems."

Made from 3D graphene foam, which offers unique capabilities when put under mechanical stress, the sensors use a piezoresistive approach - meaning when the material is put under pressure it dynamically changes its electric resistance, easily detecting and adapting to the range of pressure required, from light to heavy.

Marco Caffio, co-founder and Chief Scientific Officer at Integrated Graphene said: "Gii, our novel 3D graphene foam, has the capability to mimic the sensitivity and feedback of human touch, which could have a transformative impact on how robotics can be used for a whole range of real-world applications from surgery to precision manufacturing. We know the unique property of Gii makes it suitable for use in other applications like disease diagnostics and energy storage, so we're always very excited to be able to demonstrate its flexibility in projects like this one."

Dr. Carlos Garcia Nunez, School of Computing Engineering and Physical Sciences at UWS added: "Within robotics and wearable electronics the use of pressure sensors is a vital element, to provide either an information input system, or to give robotic systems human-like motor skills. An advanced material like 3D graphene foam offers excellent potential for use in such applications, due to its outstanding electrical, mechanical, and chemical properties. Our work shines a light on the significant potential for this technology to revolutionize the robotics industry with dynamic pressure sensors."

The next stage of the project - funded by UWS, Integrated Graphene Ltd, SRPe, and NMIS - will look to further to increase sensitivity of the sensors, before developing them for wider use in robotic systems.

Amazon plans to expand its Amazon Care offering to include behavioral health services, as well as a partnership with digital mental health company Ginger.

The new service, which hasn't launched yet, will provide Amazon Care users on-demand access to mental health experts such as licensed therapists or psychiatrists, according to people familiar with the matter and a live website about the partnership. The website says Amazon Care's coordinators will be able to refer patients to "high-quality, in-network behavioral health providers whenever possible,” Reports BusinessInsider (Amazon Care Plans to Offer Mental Health Support and Partner With Ginger (businessinsider.com))

Ginger, best known for its virtual behavioral health therapy services, is expected to become available as an additional option to Amazon Care users. The two companies will share patient information, the website says: "Amazon Care makes behavioral health a priority for your workplace. Our primary care providers treat a range of common behavioral health concerns," (...) "We've also teamed up with Ginger, an on-demand mental healthcare platform, as an optional add-on to Amazon Care."

Read more: Fujitsu and Salesforce Team Up on Healthcare Solutions (Wearable technologies (wearable-technologies.com)

The Amazon Care Service originally started as a virtual clinic for in-house employees, the service has since expanded to external employers across the country. In February, Amazon reported that it would be adding personal assistance in more than 20 new cities this year, including New York, San Francisco, Chicago and Miami.

But the tech and retail giant has a lot of ambitions in the healthcare space. Amazon announced this last month signed a definitive agreement to acquire hybrid primary care provider One Medical in a cash deal valued approximately $3.9 billion.

"Having a physical footprint with brick and mortar really helps expand their continuum of care," Sanjula Jain, senior vice president for market strategy and chief research officer at Trilliant Health, said on HIMSS TV. "Now being truly in the primary care space makes their earlier investments make a lot more sense. Now there's a way to actually integrate that into the care delivery process."

Ginger was founded in 2011 by entrepreneurs and data scientists at the MIT Media Lab. In October 2021 Ginger completed its merger with stress, sleep, and meditation app Headspace to form Headspace Health. Prior to the deal, the virtual mental health company had raised $100 million in a Series E funding round.

Researchers at the University of Washington say they have developed a first-of-its-kind flexible, wearable thermoelectric device that converts body heat to electricity, which offers a promising way to continuously power wearable electronics. The device, say the researchers, is soft and stretchable, yet sturdy and efficient — properties that can be challenging to combine.

“It’s a 100% gain if we harvest thermal energy that would otherwise be wasted to the surroundings,” says Mohammad Malakooti, a UW assistant professor of mechanical engineering. “Because we want to use that energy for self-powered electronics, a higher power density is needed. We leverage additive manufacturing to fabricate stretchable electronics, increase their efficiency and enable their seamless integration into wearables while answering fundamental research questions.”

Even after more than 15,000 stretching cycles at 30% strain, the prototype device remains fully functional, say the researchers – a highly desirable feature for wearable electronics and soft robotics. The device also shows a 6.5 times increase in power density compared to previous stretchable thermoelectric generators, reports Smart2Zero.

To create flexible devices, the researchers 3D-printed composites with engineered functional and structural properties at each layer. The filler material contained liquid metal alloys, which provide high electrical and thermal conductivity. These alloys address limitations in previous devices, including an inability to stretch, inefficient heat transfer, and a complex fabrication process.

The researchers also embedded hollow microspheres to direct the heat to the semiconductors at the core layer and reduce the weight of the device. The researchers showed that they could print these devices on stretchable textile fabrics and curved surfaces, which suggests that future devices could be applied to clothing and other objects.

“One unique aspect of our research is that it covers the whole spectrum, all the way from material synthesis to device fabrication and characterization,” says Malakooti, who is also a researcher at the UW’s Institute for Nano-Engineered Systems. “This gives us the freedom to design new materials, engineer every step in the process, and be creative.”

Blue Spark Technologies Inc produces TempTraq, an FDA Cleared Class II medical device that gives Healthcare providers the first wireless continuous temperature monitor in the form of a soft, comfortable, disposable patch. TempTraq can significantly improve the way temperature is measured in the clinical environment and provides clinicians with a quicker, easier, and more effective way to measure temperature.

Accuracy and equivalency in three hospital studies:

• Cleveland Clinic
• University Hospitals Seidman Cancer Center
• Cincinnati Children’s Hospital

In a clinical study conducted by University Hospitals Seidman Cancer Center, TempTraq was shown to detect temperature rises earlier than the standard of care by a median of 140.1 minutes (range of 30-180 minutes) with bone marrow transplant patients.

WT thinks this is what earns TempTraq the title “Innovation of the Month”.

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