Whoop refuses to back down after FDA calls blood pressure feature a medical device

Whoop has landed in hot water with the U.S. Food and Drug Administration (FDA) over one of its most eyebrow-raising features: Blood Pressure Insights.

According to a formal warning letter issued to the company, the FDA believes the feature amounts to an unapproved medical device, and says Whoop is marketing it without the proper regulatory clearance.

Whoop, on the other hand, strongly disagrees and has no plans to take it down.

The feature in question was introduced with the Whoop 5.0 and Whoop MG, along with Lifespan, which is now also available for Whoop 4.0 users, providing users with estimates of systolic and diastolic blood pressure based on proprietary algorithms and biometric data.

While Whoop stops short of calling these “medical measurements,” the interface looks and feels like it’s giving you a blood pressure reading, down to normal ranges and flagged trends.

The FDA argues that by offering this level of insight, Whoop is presenting health metrics that could influence diagnosis or treatment, effectively entering regulated territory without certification.

Whoop’s response: “We stand by it”

In response to the letter, Whoop maintains that Blood Pressure Insights are intended for general wellness and are not meant to replace clinical-grade monitors or influence treatment decisions.

A spokesperson for the company told 9to5Google that the feature is “distinctly different” from medical blood pressure monitoring tools.

So far, Whoop hasn’t pulled the feature and shows no sign of doing so.

If you’ve been using Blood Pressure Insights as part of your daily wellness routine, you might be wondering if it’s safe to rely on.

The key point here is that Whoop’s estimations are not the same as using a validated blood pressure cuff, and should be treated as general trends rather than precise readings.

Still, the FDA’s move is a signal that smartwatch health tech is under increasing scrutiny, especially as brands like Whoop, Apple, Samsung, and Garmin continue to blur the line between wellness and clinical-grade monitoring.

For now, Blood Pressure Insights remain live on the Whoop platform.

But the FDA’s letter is a shot across the bow, raising questions not just for Whoop, but for the entire wearables industry.

As health tracking becomes more advanced, the lines between coaching, diagnosing, and treating continue to shift, and regulators are watching closely.