Whoop
What medtech firms can learn from Whoop’s warning letter
· Reported by MedTech Dive
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.
More Whoop this month
- I Tracked My Health With Whoop, and This Is What I Liked (and What I Ignored)
- I’ve Tested the Whoop Band for Almost 3 Years: Here’s How I’ve Used It
- FDA scrutiny of WHOOP signals challenges for niche wearable device makers
- WHOOP Year in Review 2025: Inside a Record-Breaking Year of Sleep, Strength, and Longevity
- Whoop There It Is: FDA Warning Letter Now Anchors a Class Action Against Whoop
- I’m A Runner With A Family History Of Heart Disease—Here’s What The Whoop MG Taught Me