The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...
The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...
Wearable health devices may soon operate under looser regulatory oversight following new guidance from the FDA ...
New artificial intelligence-enabled health wearable devices and clinical decision support software will not face U.S. Food and Drug Administration regulatory ...
For other agencies, recalls mean removing products from the market, but with FDA medical device recalls, products are often allowed to stay in the market, CBS News reported Aug. 13. These “non-recalls ...
On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...
FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...
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