Whoop
What medtech firms can learn from Whoop’s warning letter
· By Endurance Wire
An FDA warning letter about the wearable company’s blood pressure feature raises questions about the blurring lines between medtech and wellness. Sometimes, the line between medical and wellness products can blur. Regulators’ pushback on a blood pressure feature that Whoop incorporated into its wellness wristband illustrates the challenges wearables developers face as they add increasingly sophisticated features. Whoop received a warning letter from the Food and Drug Administration this summer after rolling out the blood pressure offering without regulatory authorization.