Whoop
FDA drops Whoop warning letter over blood pressure feature
· By Endurance Wire
Whoop made changes to its blood pressure insights feature that satisfied the FDA’s requirements for wellness devices. When the FDA sent a warning letter to Whoop in July, the agency said blood pressure is inherently related to medical diagnosis. The letter sparked a debate about whether blood pressure should be regulated as a medical device or a wellness feature, with CEO Ahmed defending the feature and many medtech experts saying the FDA was likely to hold its ground.
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