Whoop
FDA drops blood pressure device enforcement against Whoop
· By Endurance Wire
The FDA has sent an End of Enforcement notice to consumer wearable device company Whoop, putting a formal end to the agency’s investigation into its blood pressure tech use. Last July, the FDA issued a warning letter specific to Whoop's “Blood Pressure Insights” (BPI) feature, saying it was becoming a medical device that would require proper 510(k) clearance. But in January of this year, the FDA reversed course, saying the company's wearable can, in fact, fall under “general wellness” exemptions, rather than requiring the U.S. regulator's stricter medical device clearance.
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