Flow, a medical device company launches a medication-free treatment for depression comprising a brain stimulation headset and therapy app. In Europe, Flow has been approved as a Class II medical device intended for use as a treatment for depression - and is the first approved treatment of its kind in Europe available to buy and use at home.Flow BackgroundBased in Sweden, Flow was developed by clinical psychologist Daniel Mansson and neuroscientist Erik Rehn, together with a team of prominent
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Wearables in Healthcare| Medical Grade | News, Analysis, Insights - HIT Consultant
Study: Fitbit Devices Could Predict Inflammatory Bowel Disease (IBD) Flare-Ups
Fitbit devices could help predict the flare-ups of inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, according to a new study published in the Journal of Crohn's and Colitis. The year-long study, which was recently presented at Digestive Disease Week, was conducted by the University of Chicago.Impact of IBD Flare-UpsEven when managed well, IBD can flare up or cause symptoms unexpectedly, which may be triggered by diet, stress, and physical activity (or lack
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3 Major Problems With the Medical Device and Wearables Market in 2019
Technology can improve human life in significant ways and aid in the fight against troublesome illnesses. Unfortunately, no technology is perfect — and newer technologies are especially prone to growing pains.There are three major problems in today's medical devices and wearables market: potential sabotage of the devices themselves, devices as a backdoor into networks and patient data, and device manufacturers taking advantage of regulatory loopholes to get their products on the market.1. Many
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FDA Clears First Smartphone-Controlled Migraine Wearable Device
Today, Theranica announced that the FDA has granted De Novo clearance for Nerivio Migra, the first-ever smartphone controlled wearable for the acute treatment of migraines. Worn on the upper arm, Nerivio Migra utilizes remote electrical neuromodulation for the acute treatment of migraine that is proven to be as effective as leading devices and drugs on the market in treating acute migraine, with fewer and more mild side effects.Migraine is the third most common disease in the world, with an
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NightWare Awarded FDA “Breakthrough Status” for PTSD Apple Watch App
NightWare, Inc., digital therapeutics for mental health company has received Breakthrough Status designation from the U.S. Food and Drug Administration (FDA) for its NightWare Apple Watch app that measures and treats nightmares in people with Post-Traumatic Stress Disorder (PTSD).Impact of Nightmare DisordersNightmares and Nightmare Disorder have been linked to increased suicidality, heightened risk of heart disease, diabetes, and contributes to cognitive difficulties such as memory loss,
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Bioelectronic Medicine Startup Cala Health Nabs $50M for Wearable Neuromodulation Therapies
Cala Health, Inc., a San Francisco, CA-based bioelectronic medicine company developing wearable therapies for chronic disease has raised $50 million in Series C funding. New investors in the Series C funding round include Novartis, Baird Capital, LifeSci Venture Partners, TriVentures, and others. All existing investors participated in the round, including Johnson & Johnson Innovation – JJDC, Inc. (JJDC), Lux Capital, Lightstone Ventures, Action Potential Venture Capital, dRx Capital, and
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Fitbit Charge 3 Now Available to Eligible UnitedHealthcare Motion Participants
Wearable fitness leader Fitbit today announce the next phase of its integration with UnitedHealthcare Motion by offering Fitbit Charge 3 as a buy-up option to eligible program participants. Fitbit Inspire HR™, Fitbit’s first device designed to meet the specific needs of the healthcare industry, will also be offered to program participants later this year. This integration builds on Fitbit’s history of working with UnitedHealthcare; Charge 2 was the first wearable device offered as a buy-up
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Fitbit Health Solutions Business Grew 70%, $30.5M in Revenue in Q1 2019
Fitbit today released its Q1 2019 earnings reporting revenue of $272 million, GAAP net loss per share of $(0.31), non-GAAP net loss per share of $(0.15), GAAP net loss of $(79) million, non-GAAP net loss of $(38) million, cash flow from operations of $(68) million and free cash flow of $(74) million.Q1 2019 Fitbit Health Solutions EarningsFitbit Health Solutions business grew 70% YOY with revenue of $30.5M, which was an important contributing factor to the company’s positive momentum overall in
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Cardiogram’s Wearable Based Monitoring Tool Is Now Covered by Oscar
Cardiogram is a digital health company announced that it's wearable-based monitoring for atrial fibrillation and diabetes is now covered by Oscar Health Insurance, without paying out of pocket. The coverage will help provide end-to-end preventive care: continuous wearable monitoring, convenient testing, contextualized results, and clinical triage.Impact of Chronic ConditionsFor chronic conditions like diabetes, atrial fibrillation, hypertension, and sleep apnea, anywhere between 20–80% of cases
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Onera Health Raises $9.3M to Pilot Medical Grade Sleep Diagnostics Patch
Onera Health Inc., a Palo Alto, CA-based sleep diagnostic solutions and services provider announced it raised $9.3 million in Series A funding led by Jazz Pharmaceuticals, imec.xpand, as well as other investors including imec and BOM. The digital health startup’s vision is to transform sleep diagnostics with the development of the world’s first at-home medical grade sleep diagnostics patch system.1 Out of 5 People Suffer From A Sleep DisorderThe need for better sleep testing is great. One in
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