OMRON Healthcare has secured De Novo authorisation from the US Food and Drug Administration (FDA) for new home blood pressure monitors with AI-powered atrial fibrillation (AFib) detection feature.
The FDA has granted a de novo clearance to a wearable device—with a form factor you’re familiar with—that can check patients ...
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Apple Watch series AFib monitor getting FDA medical certificationThe Galaxy Watch AFib monitor is sold in this condition. The same applies to the equivalent features of Fitbit and Google Pixel Watch devices. Now, as reported by 9to5Mac, the Apple Watch AFib ...
2024 /PRNewswire/ -- In a pivotal stride to address the growing AFib epidemic, OMRON Healthcare today announced the U.S. Food and Drug Administration (FDA) has granted the company its De Novo ...
OMRON Healthcare has secured De Novo authorisation from the US Food and Drug Administration (FDA) for new home blood pressure monitors with AI-powered atrial fibrillation (AFib) detection feature.
Risk factors for AFib include high blood pressure, obesity, diabetes, smoking, heavy use of alcohol ... products include a full range of home blood pressure monitors, nebulizers and TENS devices.
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