Wearables in Healthcare | Medical Grade Wearables - HIT Consultant https://hitconsultant.net/category/digital-health-2/wearables/ Mon, 08 Jan 2024 21:00:46 +0000 en-US hourly 1 Samsung Expands Its Privileged Health SDK Partner Program https://hitconsultant.net/2024/01/08/samsung-expands-its-privileged-health-sdk-partner-program/ https://hitconsultant.net/2024/01/08/samsung-expands-its-privileged-health-sdk-partner-program/#respond Mon, 08 Jan 2024 16:30:00 +0000 https://hitconsultant.net/?p=76559 ... Read More]]>

What You Should Know:

Samsung Electronics is pushing the boundaries of preventive healthcare with the expansion of its Privileged Health Software Development Kit (SDK) program.

– This SDK expansion unlocks the Galaxy Watch’s cutting-edge sensor technology for developers, fostering partnerships that bring a wave of innovative health solutions to users.

Empowering Users with Personalized Health Insights

At the heart of this program lies user empowerment. By integrating Galaxy Watch data with diverse platforms, Samsung and its partners empower individuals to actively manage their health. From real-time vital sign monitoring to personalized sleep environments, the focus is on proactive well-being.

Remote Patient Monitoring: Bridging the Distance

The Galaxy Watch becomes a bridge between patients and their healthcare providers, enabling seamless remote monitoring. Partners like Biofourmis and Kencor Health leverage the watch’s biometric data to deliver personalized care and predict potential health issues, allowing for timely interventions and improved clinical management.

Heart Health and Beyond: AI-powered Insights for Everyone

Medical AI’s advanced ECG services, powered by the Galaxy Watch’s technology, provide real-time arrhythmia detection and proactive alerts for patients with heart conditions. Oova, an AI-powered women’s health platform, integrates menstrual cycle data with Galaxy Watch biometrics, offering personalized guidance and precise fertility predictions.

XR Therapy at Home: Immersive Wellness Within Reach

Samsung’s partnership with XRHealth brings extended reality (XR) therapy to the comfort of home. By monitoring heart rate during virtual exercise sessions, the Galaxy Watch acts as a real-time pacer, providing valuable feedback for personalized physical and mental health therapy. Healium’s bio-feedback platform utilizes Galaxy Watch data to create immersive visual experiences, helping users understand and manage stress levels through intuitive visual feedback.

Personalized Sleep: A Holistic Approach to Rest

Recognizing the importance of sleep for overall health, Samsung is expanding its sleep technology beyond the Galaxy Watch. Partnerships with smart mattress companies like 3Boon1 create personalized sleep environments that optimize temperature for uninterrupted rest. By combining Galaxy Watch data with the mattress’s AI algorithm, users can achieve optimal sleep conditions, tailored to their individual needs.

]]>
https://hitconsultant.net/2024/01/08/samsung-expands-its-privileged-health-sdk-partner-program/feed/ 0
Withings Launches ScanWatch Nova: A Luxurious Health Scanner on Your Wrist https://hitconsultant.net/2023/12/05/withings-launches-scanwatch-nova/ https://hitconsultant.net/2023/12/05/withings-launches-scanwatch-nova/#respond Tue, 05 Dec 2023 15:00:00 +0000 https://hitconsultant.net/?p=75977 ... Read More]]>

What You Should Know:

Withings, the pioneer of hybrid smartwatches, unveils its latest innovation: ScanWatch Nova.

– This timepiece seamlessly blends cutting-edge health-tracking technology with exquisite diver-style aesthetics, making it the perfect companion for health-conscious individuals who appreciate luxury.

A Powerful Health Scan on Your Wrist

ScanWatch Nova boasts an array of health-focused features, including:

  • On-demand medical-grade ECG: Monitor your heart rhythm for potential anomalies like atrial fibrillation with a 30-second recording.
  • 24/7 body temperature tracking: Gain insights into potential illnesses and optimize workout recovery through continuous temperature variation monitoring.
  • Blood oxygen (SpO2) measurement: Assess your respiratory system’s health and gain valuable data during workouts.
  • In-depth sleep analysis: Track sleep phases, duration, interruptions, and receive personalized advice for improvement.
  • Advanced activity tracking: Monitor steps, calories, elevation, routes, and automatically recognize over 40 activities.

Luxury Design Meets Cutting-Edge Technology

The ScanWatch Nova is more than just a health tracker; it’s a statement piece. Its exquisite design features include:

  • Ceramic and stainless-steel rotating bezel: Inspired by classic diver watches, with clear markings and Luminova hands and indices for low-light visibility.
  • Refined sunray dial and mirror-polished stainless-steel case: Elegance meets durability in this exquisite watch.
  • 10 ATM water resistance and sapphire glass: Built to withstand the elements and everyday wear.
  • User-friendly OLED display: Clear and customizable, displaying vital health metrics and notifications.

A Seamless Health Journey with the Withings App

The ScanWatch Nova pairs flawlessly with the Withings app, offering:

  • Intuitive interface: Easily customize your watch display, set notifications, and track trends.
  • Personalized insights and recommendations: Gain actionable guidance to optimize your health journey.
  • Long press and quick look options: Launch your preferred feature or activate the display with a simple wrist movement.

Availability and Pricing

The ScanWatch Nova is available for pre-order online at Withings.com starting December 5th, 2023, for $599.95. It comes in blue, green, and black, with both oyster and FKM wristbands included. Retail partners will begin carrying the watch in February 2024.

With the ScanWatch Nova, Withings has redefined the health tracker. It’s a powerful health monitor, a luxurious timepiece, and a testament to cutting-edge technology, all beautifully wrapped in one.

]]>
https://hitconsultant.net/2023/12/05/withings-launches-scanwatch-nova/feed/ 0
Ambiq and Xiaomi Partner on Xiaomi Smart Band 8 Wearable Featuring Advanced Health and Wellness Monitoring https://hitconsultant.net/2023/11/17/ambiq-and-xiaomi-partner-on-xiaomi-smart-band-8-wearable/ https://hitconsultant.net/2023/11/17/ambiq-and-xiaomi-partner-on-xiaomi-smart-band-8-wearable/#respond Fri, 17 Nov 2023 16:26:00 +0000 https://hitconsultant.net/?p=75640 ... Read More]]> Ambiq and Xiaomi Partner on Xiaomi Smart Band 8

What You Should Know:

Ambiq®, a provider of ultra-low-power semiconductors for IoT endpoints, has announced a new collaboration with Xiaomi, a global provider in consumer electronics and smart manufacturing, to develop the Xiaomi Smart Band 8.

– This new smart band is designed to help consumers define their unique style while providing them with a wide range of health and fitness features.

Xiaomi Smart Band 8: A Reimagined Wearable Experience

The Xiaomi Smart Band 8 marks a significant leap forward in wearable technology, offering a comprehensive suite of features and functionalities that redefine the smart band category. Powered by Ambiq’s Apollo4 Blue Lite SoC, the Smart Band 8 delivers exceptional performance while maintaining remarkable power efficiency, enabling users to enjoy a seamless and extended experience.

Advanced Health and Wellness Monitoring

The Smart Band 8 is equipped with a range of health and wellness monitoring capabilities, including:

– Continuous SpO2 and heart rate monitoring: Keep track of your oxygen saturation levels and heart rate throughout the day to stay informed about your overall health and well-being.

– Comprehensive sleep monitoring: Gain valuable insights into your sleep patterns, including sleep stages and sleep quality, to optimize your rest and improve your daytime performance.

– Pressure monitoring: Monitor your blood pressure levels regularly to proactively manage your cardiovascular health.

– Female menstrual cycle tracking: Stay informed about your menstrual cycle and receive personalized predictions for your period and ovulation days.

Enhanced User Experience

The Smart Band 8 boasts an array of features that enhance the user experience:

– 200+ pre-set watch faces: Customize your band to match your style with a wide selection of watch faces.

– 1.62″ crystal clear high-resolution AMOLED display: Enjoy vibrant colors and sharp text on a larger, improved display.

– 190mAh battery: Experience up to 16 days of typical usage on a single charge, ensuring that your band stays powered up throughout your day.

– 150+ sports modes: Choose from a wide range of sports modes to track your workouts and achieve your fitness goals.

The Xiaomi Smart Band 8 is now available for purchase. For more information, please visit the Xiaomi website.

]]>
https://hitconsultant.net/2023/11/17/ambiq-and-xiaomi-partner-on-xiaomi-smart-band-8-wearable/feed/ 0
Meet The Circular Smart Ring Slim, The Slimmest and Lightest Smart Ring in the World https://hitconsultant.net/2023/11/15/meet-the-circular-smart-ring-slim-the-slimmest-and-lightest-smart-ring-in-the-world/ https://hitconsultant.net/2023/11/15/meet-the-circular-smart-ring-slim-the-slimmest-and-lightest-smart-ring-in-the-world/#respond Wed, 15 Nov 2023 16:22:01 +0000 https://hitconsultant.net/?p=75537 ... Read More]]>

What You Should Know:

  • Following the success of the groundbreaking Circular Ring Pro, Circular, pioneers of smart ring technology, is excited to unveil the Circular Ring Slim, the thinnest, and lightest, most intuitive smart ring in the world and the first to incorporate haptic navigation and alerts.
  • Paired with Kira+, Circular’s powerful AI wellness assistant, the sleek Circular Ring Slim assesses 7 biometrics and 142 derived markers 24/7 to help people sleep better and live healthier lives. By optimizing physical activities and maintaining mental wellness it is making personalized, preventative health a reality. 

Circular Ring Slim – Miniature but Mighty

 Circular is innovating the next wave of remote monitoring solutions, seamlessly integrated into highly wearable smart rings for both consumers and health professionals. The Circular Ring Slim, the company’s second iteration, succeeds the Circular Ring Pro, embodying constant use for a comprehensive health circle.Weighing a mere 2 grams and measuring 2.2 mm thick, the Circular Ring Slim claims the title of the world’s slimmest and lightest wearable. It boasts advanced sensors, a 6-day battery life, and 20 days of memory, ensuring continuous day-and-night wear. The ring gathers health data every 2 minutes, providing 15 times more information than competitors.

This ultra-thin design, crafted from matte black titanium, combines comfort with style. It captures various health metrics, including activity levels, blood oxygen, energy, calories, heart and respiration rates, and chronotype during the day. At night, it monitors circadian rhythm, sleep quality, disturbances, REM cycles, and temperature variations for early illness detection. Distinctively, the Circular Ring Slim introduces haptic navigation and feedback. Users tap inputs around the ring, and haptic vibrations offer feedback and drive features like the Smart Alarm Clock, Medication Reminders, and Guided Breathing Exercises.

Augmenting the ring’s capabilities is Kira+, an AI-powered health assistant, providing personalized insights and recommendations without subscription fees. Kira+ analyzes data over a 14-day period, understanding user habits to deliver tailored health advice, predict potential issues, and offer motivation through gamification strategies within the Circular app.

Circular’s app is compatible with popular health platforms like Google Fit and Apple HealthKit, ensuring seamless integration with other health apps.

]]>
https://hitconsultant.net/2023/11/15/meet-the-circular-smart-ring-slim-the-slimmest-and-lightest-smart-ring-in-the-world/feed/ 0
In-Ear Wearable Measures Blood Flow to the Head for Long COVID POTS https://hitconsultant.net/2023/11/13/in-ear-wearable-measures-blood-flow-to-the-head-for-long-covid-pots/ https://hitconsultant.net/2023/11/13/in-ear-wearable-measures-blood-flow-to-the-head-for-long-covid-pots/#respond Mon, 13 Nov 2023 20:51:45 +0000 https://hitconsultant.net/?p=75475 ... Read More]]>

What You Should Know:

  •  STAT Health emerges from stealth to introduce a 24/7 in-ear wearable that measures blood flow to the head to better understand symptoms such as dizziness, brain fog, headaches, fainting, and fatigue that occur upon standing.
  • These are common symptoms for illnesses like long COVID, postural orthostatic tachycardia syndrome (POTS), myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS), and other orthostatic (caused by standing) syndromes that affect more than 13 million Americans. Clinically tested at Johns Hopkins and peer-reviewed in the March 2023 issue of Journal of the American College of Cardiology (JACC), the device has been shown to predict fainting minutes before it happens.

Blood Flow to the Head is What Matters; The Ear as a Biometric Gold Mine

Numerous individuals grappling with conditions such as long COVID, POTS, and ME/CFS experience symptoms resulting from diminished blood flow to the brain upon assuming an upright position. Despite being theoretically recognized, substantiating this phenomenon experimentally has proven challenging until recently. Physicians affiliated with Johns Hopkins, Brigham and Women’s, and Harvard Medical School have successfully utilized ultrasound to validate that Cerebral Blood Flow (measured through ultrasound in cerebral arteries as a means of quantifying blood flow to the head) serves as a pivotal biomarker. This objective measure effectively gauges the existence and intensity of various “invisible illnesses.”

“Cerebral Blood Flow (CBF) is the critical missing vital sign – poor CBF is the cause of common orthostatic symptoms such as dizziness and brain fog. My Dutch colleagues have measured this with ultrasound on over a thousand patients.” said Peter Rowe, M.D., Sunshine Natural Wellbeing Foundation Professor of Chronic Fatigue and Related Disorders, Johns Hopkins Medicine. “However, it’s not easy to measure CBF, so most clinics approximate using secondary metrics of Heart Rate and Blood Pressure, which often mislead. Unfortunately, this frequently leads to the wrong conclusion that the symptoms are just psychological, when in fact, there are physiological abnormalities.”

To fit into a wearable form factor, STAT uses an optical sensor instead of ultrasound and taps into a shallow ear artery to measure a proxy to ultrasound-derived Cerebral Blood Flow. 

]]>
https://hitconsultant.net/2023/11/13/in-ear-wearable-measures-blood-flow-to-the-head-for-long-covid-pots/feed/ 0
Withings Health, Vida Health Partner to Enhance Virtual Cardiometabolic Care https://hitconsultant.net/2023/11/07/withings-health-vida-health-partner-to-enhance-virtual-cardiometabolic-care/ https://hitconsultant.net/2023/11/07/withings-health-vida-health-partner-to-enhance-virtual-cardiometabolic-care/#respond Tue, 07 Nov 2023 17:03:00 +0000 https://hitconsultant.net/?p=75325 ... Read More]]>

What You Should Know:

Vida Health, a virtual cardiometabolic care provider and wearables provider Withings Health Solutions has partnered to provide Vida members with state-of-the-art remote monitoring devices, including the Withings Body Pro cellular scale and the BPM Connect Pro cellular blood pressure monitor.

– Eligible Vida members will receive Withings Body Pro cellular scales, BPM Connect Pro cellular blood pressure monitors, or both. Vida’s care teams will gain access to consistent and accurate patient-generated health data, improving their personalized care approach.

Elevate Patients’ User Experience and Improve Vida’s Operational Capabilities

The collaboration aims to enhance the patient experience by providing Vida members access to high-quality monitoring devices, facilitating meaningful discussions with healthcare providers, and establishing actionable health goals. By integrating Withings’ cellular scale and blood pressure monitor, Vida not only enhances the user experience but also streamlines its operations, leveraging reliable data and achieving operational efficiency.

“Patient experience is frequently marginalized as a “nice to have” within the healthcare industry. Yet, with Vida​,​ we share the belief that it actually is a “must-have​.​” Great experiences not only foster​     ​ patient engagement but also lead to better health outcomes,” said Antoine Robiliard, VP of Withings Health Solutions. “Our cellular devices ensure that Vida’s care teams​ continuously​receive​ accurate and reliable measurements to make more informed and timely decisions. With a joint focus on enhancing the patient experience, we aim to drive consistent program engagement while reducing the long-term costs of living with and managing a chronic condition.” 

Vida Health Background

Vida’s virtual cardiometabolic care solutions serve clients across the United States, offering proven clinical outcomes for various conditions such as obesity, diabetes, hypertension, and more.

Withing Health Solutions Background

Withings Health Solutions focuses on delivering powerful health devices that can be seamlessly integrated into third-party ecosystems, catering to medical professionals, institutions, and remote patient monitoring programs.

]]>
https://hitconsultant.net/2023/11/07/withings-health-vida-health-partner-to-enhance-virtual-cardiometabolic-care/feed/ 0
BARDA, Evidation Expand Partnership for Early Detection of Influenza-like Illness Using Wearables https://hitconsultant.net/2023/10/18/barda-evidation-expand-partnership/ https://hitconsultant.net/2023/10/18/barda-evidation-expand-partnership/#respond Wed, 18 Oct 2023 14:08:00 +0000 https://hitconsultant.net/?p=74863 ... Read More]]> Evidation Health Lands $45M to Expand into Virtual Health Market, Appoints Chief Commercial Officer

What You Should Know: 

Evidation has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services (HHS), to fund the 2023 Influenza-like Illness (ILI) Detect & Protect Studies.

– This contract will also fund research to expand and better understand the potential impact of Evidation’s FluSmart program to encourage protective health behaviors. FluSmart pairs machine learning predictions with behavioral nudges, education, and personalized insights to help people better understand their risk of flu-like illness and take early action to help prevent transmission and severe disease.

Detect & Protect Studies

The Detect & Protect Studies will support the development of machine learning models to detect respiratory viral infections with data collected from consumer-grade wearable devices. This research will take place during the 2023-24 cold and flu season and bring together new devices and data types, serial PCR testing, and Evidation’s health measurement and engagement platform to create next-generation models for earlier and pre-symptomatic detection of COVID-19, influenza A and B, and respiratory syncytial virus (RSV).

The expanded partnership is the third BARDA award issued to Evidation to advance understanding and detection tools for respiratory infections. The first award funded the Home Testing of Respiratory Illness Study, a prospective flu monitoring study and benchmark dataset that used consumer wearables, self-reported symptoms, and PCR testing to understand and characterize respiratory virus onset. 

“Since our first study with BARDA in December of 2019, with the participation and consent of hundreds of thousands of Americans nationwide, we’ve learned how high-resolution data from consumer grade wearables–heart rate, sleep, physical activity and other more specific signals–can help identify when someone may be experiencing symptoms of flu-like illness,” said Christine Lemke, co-founder and CEO of Evidation. “We are excited to expand, validate, and improve our models, and find new ways to prompt people to take appropriate action when it matters most.”

]]>
https://hitconsultant.net/2023/10/18/barda-evidation-expand-partnership/feed/ 0
iRhythm Launches Wearable ECG Heart Monitor https://hitconsultant.net/2023/09/26/irhythm-launches-wearable-ecg-heart-monitor/ https://hitconsultant.net/2023/09/26/irhythm-launches-wearable-ecg-heart-monitor/#respond Tue, 26 Sep 2023 13:30:00 +0000 https://hitconsultant.net/?p=74470 ... Read More]]>

What You Should Know:

  • iRhythm Technologies, Inc. today announced the U.S. launch of its next-generation Zio® monitor and enhanced Zio® long-term continuous monitoring (LTCM) service.
  • Zio monitor is iRhythm’s smallest, lightest and thinnest cardiac monitor, enhancing the cardiac monitoring experience for patients and healthcare providers together with new service enhancements. The new Zio monitor is a prescription-only ECG monitor, which is an integral part of the Zio LTCM service. The Zio LTCM service consists of a patch ECG monitoring device (Zio monitor), the ZEUS (Zio ECG Utilization Software) System – iRhythm’s advanced AI algorithm which supports the capture and analysis of ECG data recorded by Zio monitor – and a comprehensive end-of-wear report which is reviewed by certified cardiographic technicians. This end of wear report has a 99% physician agreement.

Improving Long-Term Continuous Monitoring Modalities for Better Cardiac Outcomes

“We’ve made our best product even better – early clinical and patient experience shows that Zio monitor has even better wear times, comfort and patient experience,” said Mintu Turakhia, MD, MAS, Chief Medical Officer, Chief Scientific Officer and Executive Vice President, Product Innovation at iRhythm. “When you combine our new Zio monitor with our advanced AI, efficient workflow, patient and clinician apps, and easy-to-read and actionable clinical reports, we continue to lead the way in the field.”

The Zio monitor aims to enhance diagnostic accuracy and provider efficiency while providing an improved patient experience with extended wear for up to 14 days. It builds upon the successful Zio® XT monitor with the following key features:

  1. Enhanced Patient Comfort: It boasts a 23% thinner, 62% lighter, and 72% smaller form-factor compared to its predecessor, weighing less than a pencil.
  2. Consistent Patient Adherence: The Zio monitor maintains an impressive 99% patient compliance with prescribed wear times, ensuring healthcare providers can achieve accurate diagnoses on the first attempt.
  3. User-Friendly Design: Its design incorporates breathability, a hydrocolloid adhesive, and a waterproof housing. Moreover, it requires no device or adhesive manipulation or battery replacement throughout the entire 14-day wear and monitoring period.

iRhythm is launching a redesigned MyZio® patient app alongside the new Zio monitor. The app offers a better user experience with easier symptom tracking, educational content, and an improved help center. iRhythm is also enhancing patient support for insurance-related inquiries. These updates aim to elevate the overall experience for patients and clinics using the Zio service. 

iRhythm’s FDA-cleared AI employs a highly accurate deep-learned algorithm, matching the precision of expert cardiologists. The CAMELOT study, presented at the American College of Cardiology’s Annual Scientific Session, encompassing 287,789 patients, revealed that the Zio long-term continuous monitoring (LTCM) service, prescribed for up to 14 days, offers the highest diagnostic accuracy, lowest retesting rate, and the lowest likelihood of acute care hospitalization compared to all other monitoring services, including long-term continuous monitors.

The Zio LTCM service aids physicians in the identification, diagnosis, and management of cardiac arrhythmias. Approximately 5% of the U.S. population, nearly 16 million people, experience arrhythmias. Left untreated, these conditions can harm vital organs, increase stroke and mortality risk. Timely detection and treatment are crucial to reducing the cardiac disease burden.

]]>
https://hitconsultant.net/2023/09/26/irhythm-launches-wearable-ecg-heart-monitor/feed/ 0
Evidation, USC Partner to Integrate Wearables Dataset for Healthy Aging Study https://hitconsultant.net/2023/09/19/evidation-usc-partner-to-integrate-wearables-dataset-for-healthy-aging-study/ https://hitconsultant.net/2023/09/19/evidation-usc-partner-to-integrate-wearables-dataset-for-healthy-aging-study/#respond Tue, 19 Sep 2023 15:55:30 +0000 https://hitconsultant.net/?p=74152 ... Read More]]>

What You Should Know:

  • Evidation, the company creating new ways to measure and improve health in everyday life, today announced a partnership with USC’s Dornsife Center for Economic and Social Research to incorporate wearable device data into the landmark Understanding America Study.
  • The goal of the partnership is to power research that will generate insights into healthy aging. Evidation and USC will collaborate to integrate a robust wearables dataset into extensive survey data that has been collected as part of the Understanding America Study for almost two decades. Evidation and USC have been working together since 2017 and this work expands upon the NIH-funded American Life in Realtime (ALiR) study, an initiative that achieved a nationally representative digital health benchmark dataset. 

Making Healthcare More Accessible by Data-Driven Improvements in Wearable Devices

Launched in 2014 and supported by the National Institute on Aging (NIA) and the Social Security Administration (SSA), the Understanding America Study is a nationally representative panel of over 12,000 people across the United States. Administered by USC, UAS offers rich data from a demographically diverse set of participants on topics varying from health and wellness, work, leisure, retirement, social issues, and aging.  

Evidation will facilitate the collection of prospective wearable data from thousands of individuals to better understand and analyze activity and sleep data from everyday life. Layered on top of extensive survey data, this longitudinal wearable data will help unearth answers to key questions regarding how to extend life span, as well as healthspan – the duration someone can be healthy without chronic and debilitating disease or disability.

“Evidation’s decade plus experience consenting, curating, and making sense of wearable data makes them the ideal partner for this important expansion of the Understanding America Study. We’re excited to build on the foundation of data already available as part of UAS to uncover insights that will make it possible to extend and improve healthspan,” said Arie Kapteyn, Professor of Economics and the founding Executive Director of the Dornsife Center for Economic and Social Research at the University of Southern California. “We know that Evidation shares our commitment to use the most advanced technology in service of improving people’s health and welfare, and will bring tremendous value to this collaboration.”

]]>
https://hitconsultant.net/2023/09/19/evidation-usc-partner-to-integrate-wearables-dataset-for-healthy-aging-study/feed/ 0
FemTech: Evie Ring Establishes Medical Advisory Board for Medical-Grade Wearable to Women https://hitconsultant.net/2023/08/10/evie-ring-establishes-medical-advisory-board-for-medical-grade-wearable-to-women/ https://hitconsultant.net/2023/08/10/evie-ring-establishes-medical-advisory-board-for-medical-grade-wearable-to-women/#respond Thu, 10 Aug 2023 13:00:00 +0000 https://hitconsultant.net/?p=73392 ... Read More]]> Women’s Medical-Grade Wearable Smart Ring

What You Should Know: 

  • Movano Health (Nasdaq: MOVE), a purpose-driven healthcare solutions company at the intersection of medical and consumer devices and makers of the Evie Ring, announced the formation of its Medical Advisory Board. 
  • The initial panel is composed of healthcare industry subject matter experts in women’s health, mental health, and sleep, who will serve as trusted advisors to the Evie team regarding the development of its medical-grade smart ring for women and provide insights to establish Evie as a highly credible health and wellness resource.

Medical Advisory Board Membership

The inaugural members of the Medical Advisory Board include:

Dr. Mary Claire Haver, MD, FACOG, CCMS is a board-certified OB/GYN, author and entrepreneur who has devoted her practice to women’s health. She has helped thousands of women going through perimenopause and menopause actualize their health and wellness goals by creating The Galveston Diet integrated wellness program. With the goal of empowering and educating women, Dr. Haver took a deep dive into the science of menopause, aging, and inflammation beyond what she was taught in medical school and residency. She emerged with an evidence-based program so women could wisely invest in their most undervalued asset, their health.

Dr. Ruth C. White, PhD, MPH, MSW, RSW is a mental health expert, stress management advocate and diversity trainer. She authored the book, The Stress Management Workbook: De-stress in 10 minutes or Less, and has written articles on mental health for Harvard Business Review, Fast Company, Modern Healthcare, and more. Throughout her career, she has spent more than 20 years teaching social work at the University of Southern California, Seattle University, UC Berkeley, Fordham, and San Francisco State. Her holistic, science-based, prevention-focused approach is grounded in her experience as an elite athlete and her personal mental health journey.

Dr. Andrea Matsumura, MD, MS, FACP is a sleep medicine specialist at the Oregon Clinic who has helped thousands of people improve their sleep. She focuses specifically on sleep in women and how their sleep differs from that of men. She practiced medicine as a primary care physician for 12 years until she realized that the root of managing chronic conditions hinges on getting a good night’s rest. She graduated from the University of Texas Medical School in San Antonio and completed her internship and residency at Providence Portland Medical Center. She completed her fellowship in sleep at Oregon Health and Science University. Dr. Matsumura has appeared in countless webinars, articles, and conferences.

To certify the accuracy of Evie Ring’s heart rate and SpO2 data and earn the trust of users and doctors alike, the Company recently submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the Evie Ring’s pulse oximeter. 

]]>
https://hitconsultant.net/2023/08/10/evie-ring-establishes-medical-advisory-board-for-medical-grade-wearable-to-women/feed/ 0
FemTech: First Women’s Medical-Grade Wearable Smart Ring Submitted for FDA Clearance https://hitconsultant.net/2023/08/03/womens-medical-grade-wearable-smart-ring-fda/ https://hitconsultant.net/2023/08/03/womens-medical-grade-wearable-smart-ring-fda/#respond Thu, 03 Aug 2023 18:54:07 +0000 https://hitconsultant.net/?p=73317 ... Read More]]>

What You Should Know: 

  • Movano Health, makers of the Evie Ring, the first medical-grade wearable smart ring for women announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA). 
  • The submission has passed the first milestone of the review process, an initial review for completeness, and is now under full review by the FDA.

Medical Grade Wearable Designed Specifically for Women

The Evie Ring combines health and wellness metrics to give a full picture of one’s health: resting heart rate, heart rate variability, SpO2, respiration rate, skin temperature variability, period and ovulation tracking, menstrual symptom tracking, activity profile, including steps, active minutes and calories burned, sleep stages and duration, and mood tracking. This data is delivered through a mobile app that aims to simplify how data is presented, moving away from complex graphs and charts, and turning biometric data into actionable insights that will help women make manageable lifestyle changes and take a more proactive approach to mitigating the risks of chronic disease.

Evie Ring’s Clinical Performance

One of the most critical components of the FDA submission is the ring’s clinical performance. In Q4 2022, Movano Health completed a successful pivotal hypoxia trial with the University of California, San Francisco (UCSF) to assess the accuracy of Evie’s blood oxygen saturation (SpO2). In comparing the overall accuracy of the ring’s data with data from arterial blood gas data, the Evie Ring achieved an approximate 2% margin of error, well below the FDA guidance of 3.5% for SpO2. In a separate nonclinical test completed by Movano Health per the standard and FDA guidance, pulse was tested over the range of 40 to 240 beats per minute (BPM) and the Evie Ring margin of error was 1 BPM, also exceeding FDA’s requirements.

“From the outset, our vision for Evie has been to develop a consumer wearable that is beautiful, accessible and personalized, as well as be cleared by the FDA as a medical device. This first submission to the FDA marks a momentous milestone for our team and sets the stage for future FDA filings,” said John Mastrototaro, CEO of Movano Health.  “The effort associated with becoming a medical device company is certainly significant, but we believe it’s a highly competitive differentiator and a strong asset when compared to existing wellness solutions. It also is expected to enable significant partnership opportunities with healthcare and other enterprises. We look forward to working with the FDA through the review process.”

]]>
https://hitconsultant.net/2023/08/03/womens-medical-grade-wearable-smart-ring-fda/feed/ 0
Aevice Health Secures FDA Clearance for Smart Stethoscope Wearable for Respiratory Monitoring https://hitconsultant.net/2023/07/20/aevice-health-fda-clearance-smart-stethoscope-wearable/ https://hitconsultant.net/2023/07/20/aevice-health-fda-clearance-smart-stethoscope-wearable/#respond Thu, 20 Jul 2023 20:25:39 +0000 https://hitconsultant.net/?p=73108 ... Read More]]>

What You Should Know: 

Aevice Health, a Singapore-based provider of remote respiratory monitoring solutions today announced that its AI-powered, smart stethoscope wearable, the AeviceMD, has received clearance from the U.S. Food and Drug Administration (FDA) as a Class II medical device under the 510(k) route. 

– This clearance empowers the company to market and provide their novel remote monitoring platform to health systems across the country, expanding access to a hassle-free and convenient solution for assessing lung health in clinical and home settings.

Remote Respitoring Monitoring Platform

The AeviceMD is an integral part of the broader AeviceMD Monitoring System, a comprehensive patient management platform targeted towards chronic respiratory disease management. Leveraging cutting-edge proprietary algorithms, the AeviceMD Monitoring System continuously monitors biomarkers of interest acquired by its smart wearable stethoscope and detects early signs of respiratory exacerbation. The robust platform has completed trials in the emergency department for the analysis of abnormal lung sounds like wheezing against the current standard of care — the clinicians’ own stethoscope-based analysis. The results from these trials are currently being collated and will be disclosed in a separate and forthcoming announcement.

How AeviceMD Works

With the AeviceMD, the clinic can now be brought home. The AeviceMD elevates the ubiquitous stethoscope – an essential tool in every clinic – into a smart, digital, and easily accessible device. Caregivers and patients can simply conduct auscultations using the AeviceMD sensor and conveniently share them with their healthcare professional. Through analysis of these recordings, healthcare providers can accurately identify abnormalities and promptly advise patients, enabling proactive management of lung health.

]]>
https://hitconsultant.net/2023/07/20/aevice-health-fda-clearance-smart-stethoscope-wearable/feed/ 0
Wearable Sensor Measures Sweat Lactate Levels During Exercise https://hitconsultant.net/2023/07/19/wearable-sensor-measures-sweat-lactate-levels-during-exercise/ https://hitconsultant.net/2023/07/19/wearable-sensor-measures-sweat-lactate-levels-during-exercise/#respond Wed, 19 Jul 2023 14:13:00 +0000 https://hitconsultant.net/?p=73083 ... Read More]]>

What You Should Know: 

– A team of Japanese researchers has developed a wearable device that can measure how hard one is exercising by analyzing their sweat. 

– Their findings have been published in the journal ACS Sensors. The device continuously monitors the level of lactate in our sweat, which is a good indicator of exercise intensity. This technology can be valuable for athletes and fitness enthusiasts to manage their training and monitor their overall health.

Leveraging Lactate Level in Sweat as a Biomarker

Human sweat is a rich source of health information, offering insights into a person’s hydration level, electrolyte balance, and overall physiological state. For instance, lactate level in sweat is a useful biomarker of exercise intensity. Its measurement can help estimate the amount of lactic acid in the blood and, in turn, predict muscle fatigue.

Today, wearable sensors make it possible to continuously monitor biomarkers such as sweat lactate. Using the latest microfluidics technology, scientists have developed devices that convey minuscule amounts of sweat to tiny chemical sensors, which can transmit their measurements in real time wirelessly. However, one common problem in such devices is that their microfluidic channels tend to trap air bubbles present in the sweat. If these bubbles cover the sensor’s electrodes, the measurements get interrupted, interfering with the continuous monitoring of the target biomarker. 

Research Background/Protocols

To address this issue, a research team, led by Associate Professor Isao Shitanda from Tokyo University of Science (TUS) in Japan, has come up with a novel microfluidic sweat lactate sensor whose measurements remain unaffected by the air bubbles. Their study, made available online on 22 May 2023 and published in ACS Sensors on 23 June 2023, was co-authored by Dr. Masahiro Motosuke, Dr. Tatsunori Suzuki, Dr. Shinya Yanagita, and Dr. Takahiro Mukaimoto from TUS.

The proposed wearable device consists of a relatively simple layered structure—a conventional lactate oxidase sensor attached via double-sided tape to a microfluidic system made of a silicone polymer. When the person wearing the device begins to perspire, the sweat enters the microfluidic channels via four inlets and flows toward a reservoir near which the electrodes are located. Old sweat exits the system through an outlet as new sweat enters, and a small wireless transmitter reports the measured lactate levels.

The key innovation in the proposed design was the use of a larger-than-usual sweat reservoir. “By increasing the length of the reservoir in the microfluidic channel, a space of approximately four microliters was created for trapping any air bubbles that infiltrate the device, thereby preventing them from contacting the electrodes of the sensor,” explains Dr. Shitanda. 

The researchers tested their sensor in a series of laboratory experiments. They verified that the bubble-trapping region worked as intended by injecting bubbles into the device while measuring lactate levels in artificial sweat. In addition, the measurements were not affected by the sweat flow rate, and the response of the sensor remained stable for approximately two hours. Lastly, the researchers tested the device on a male volunteer who exercised on a stationary bike for almost an hour. The sensor showed a lactate concentration correlation ranging from 1 to 50 mM as well as a correlation between sweat and blood lactate levels.

Overall, the results of this study hint at the potential of wearable microfluidic sensors for monitoring sweat biomarkers during exercise. 

Since the microfluidic system of the proposed lactate sensor is fabricated from a soft, flexible, and non-irritating material, it could be used to continuously monitor lactate levels in sweat, especially in sports and medicine,” remarks Dr. Shitanda. “Wearable lactate sensors may become useful condition management tools in sports such as soccer and basketball, allowing team managers to know when it’s best to replace a player.”

]]>
https://hitconsultant.net/2023/07/19/wearable-sensor-measures-sweat-lactate-levels-during-exercise/feed/ 0
Study: Virtual Reality Effective for Ketamine-Assisted Therapy https://hitconsultant.net/2023/06/19/virtual-reality-effective-ketamine-assisted-therapy/ https://hitconsultant.net/2023/06/19/virtual-reality-effective-ketamine-assisted-therapy/#respond Mon, 19 Jun 2023 18:10:30 +0000 https://hitconsultant.net/?p=72604 ... Read More]]>

What You Should Know: 

  • TRIPP, a global XR wellness company, announced the completion of TRIPP PsyAssist’s Phase 1 Proof Of Concept (POC) Feasibility Study. 
  • The first phase of the breakthrough study shows virtual reality (VR) as an effective tool to help patients prepare for ketamine-assisted therapy

Research Background

The study focuses on investigating the effects of a Virtual Reality (VR) experience before Ketamine dosing and was conducted at the esteemed Kadima Neuropsychiatry Institute in San Diego, with analysis provided by Valis Biosciences. The Journal of Psychopharmacology reports 50% of participants who received ketamine treatment showed significant improvement in their PTSD symptoms. Despite psychedelics gaining ground in mainstream medicine, patients still need help managing pre-session anxiety, onboarding effectively, and integrating their experiences after treatment, whether in a clinic or at home. 

Phase 1 of the TRIPP PsyAssist study aimed to determine the feasibility and acceptability of guided, meditative imagery delivered in virtual reality on the Pico Neo 3 Pro Eye headset as a pre-treatment program in a real-world clinical context. Participants for the study were recruited from patients who had already consented to receive ketamine treatments for their depression or anxiety at Kadima. The study also assessed participant satisfaction, engagement and usage to determine the feasibility and acceptability of this approach prior to these consciousness-altering experiences. 

Key preliminary findings* from the data gathered include: 

  • 80% of users reported wanting to use the system frequently. 
  • 100% of users found the various functions in the system well integrated. 
  • 90% of users imagine most people would learn to use this system quickly. 
  • 100% of users felt very confident using the system. 
]]>
https://hitconsultant.net/2023/06/19/virtual-reality-effective-ketamine-assisted-therapy/feed/ 0
Samsung’s Irregular Heart Rhythm Notification Feature Coming This Summer to 13 Markets https://hitconsultant.net/2023/06/14/samsungs-irregular-heart-rhythm-notification-feature/ https://hitconsultant.net/2023/06/14/samsungs-irregular-heart-rhythm-notification-feature/#respond Wed, 14 Jun 2023 19:03:26 +0000 https://hitconsultant.net/?p=72524 ... Read More]]>

What You Should Know: 

  • Samsung announced today that the Irregular Heart Rhythm Notification (IHRN) feature will be available to users in 13 markets starting this summer. Combined with the app’s Electrocardiogram (ECG) [3] monitoring, the IHRN feature, detects heart rhythms suggestive of atrial fibrillation (AFib), helping Galaxy Watch users understand their heart health more comprehensively.
  • According to the American Heart Organization, there will be more than 12 million people living with AFib by 2030. This new feature will allow over 15 million Galaxy Watch users to further monitor their cardiovascular health by detecting inconsistent heart rhythms and alert users of potential atrial fibrillation.
  • The Irregular Heart Rhythm Notification will be initially introduced on Galaxy Watch devices later this year with the new One UI 5 Watch update and later expanded to previous editions.
]]>
https://hitconsultant.net/2023/06/14/samsungs-irregular-heart-rhythm-notification-feature/feed/ 0