Fitbit launches Researcher Pledge and updates to their Terms of Service to help educate the research community on user privacy risks. In response to these evolving user privacy issues, Fitbit has developed a new Researcher Pledge and updates to their Terms of Service to help educate the research community on these risks and specify the commitments we require from researchers to help protect the privacy of our users. The new Research Pledge outlines best practices to help ensure research study
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Wearables in Healthcare| Medical Grade | News, Analysis, Insights - HIT Consultant
Yale, Mayo Clinic, Biofourmis Launches Research to Detect Heart Failure Using Wearable Biosensor Data
Biofourmis has entered a research partnership with the Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI). Biofourmis' mobile platform BiovitalsHFTM will be leveraged in a study of patients with heart failure to monitor functional capacity and quality of life to see if greater emphasis should be placed on these measures in the drug approval process.Impact of Heart FailureHeart failure afflicts approximately 6.5 million patients in the United States and
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Consumers Willing to Utilize Medical Wearables to Avoid Physician Visits
Consumers are willing to utilize medical wearables to overcome barriers to seeing a physician, including distance and cost, according to a recent survey by VivaLNK. The survey reveals that of 100 participants ages 40 and over, 64 percent said they would utilize a wearable health monitoring device if it meant it could reduce the number of times, they had to physically visit a doctor or hospital.3 Factors Driving Patient’s Desire to Reduce Physical Physician AppointmentsThe survey determined there
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Reaching the Healthcare Mainstream: Wearables and Remote Patient Monitoring Market Map
Even though 2014 was supposed to be the “year of the wearable” according to Forbes, five years later we are now seeing the wearable reach maturity and mass-adoption. This increase in adoption has largely been driven by software and hardware stability which is now allowing these devices to be used with confidence to manage an individual’s health and wellness, including chronic condition management. The graphic below from Accenture shows the increase in technology usage across consumers to manage
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Flow Launches Medical-Grade Headset, Therapy App for Depression
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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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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