With the US Food and Drug Administration’s (FDA) September 9, 2025 announcement that it will increase its enforcement of the Federal Food, Drug, and Cosmetics Act (FFDCA), its rules governing ...
In 2025, the U.S. Food and Drug Administration (FDA or the Agency) issued a surprising number of enforcement letters to ...
Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will ...
Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...
“The FDA’s medical experts made a thorough evaluation of the data and made the right call on the benefits outweighing the little to no risk of wearing the Q-Collar.” The BMJ paper, published by two ...
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 ...
Add Yahoo as a preferred source to see more of our stories on Google. FDA commissioner Marty Makary made the announcement during the 2026 CES trade show The US Food and Drug Administration (FDA) is ...
Woori IO plans to accelerate its noninvasive CGM launch after FDA announced relaxed wearable device regulations.
Woori IO, an OSR company developing next-generation noninvasive glucose monitoring technologies, today commented on the U.S.
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