Join gaming leaders online at GamesBeat Summit Next this upcoming November 9-10. Learn more about what comes next. Siemens has received a $1.78 million contract with the U.S. Food and Drug Administration to showcase how digital twin representations can improve medical device manufacturing. Results will be closely watched, as much is riding on such manufacturing […]
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Withings gets FDA nod for medical smartwatch ScanWatch
Join gaming leaders online at GamesBeat Summit Next this upcoming November 9-10. Learn more about what comes next. Withings said has received clearance from the Food and Drug Administration (FDA) for its medical-grade ScanWatch, a smartwatch that can detect heart rate problems. The hybrid smartwatch and medical device can detect atrial fibrillation, a heart rate […]
Cala Health Receives FDA Breakthrough Device Designation for Cala Trio™ Therapy to Treat Action Tremors in Parkinson’s Disease
— Subsequent clinical trials expected to commence in 2020 — BURLINGAME, Calif.–(BUSINESS WIRE)–October 22, 2020– Cala Health, Inc., a bioelectronic medicine company developing wearable therapies for chronic disease, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Cala Trio™ for the treatment of action tremors in the hands of […]
FDA allows AliveCor’s AI ECG to detect coronavirus drug-induced heart problems
While rivals worked to build basic ECG functionality into smartwatches, AliveCor received FDA approval last year for a first-of-kind six-lead consumer ECG — the KardiaMobile 6L — that could be positioned at multiple sites on the user’s body, gathering additional heart rate data for broader measurements and greater diagnostic accuracy. Now, as the COVID-19 outbreak continues to […]