FDA Drops Action Against Whoop Over Blood Pressure Feature

The Food and Drug Administration (FDA) informed wearable maker Whoop last week that it will not pursue further enforcement action regarding the company’s Blood Pressure Insights feature. This decision follows a July 2025 warning from the agency that the feature functioned as a medical device requiring official clearance before release.

Why did the FDA warn Whoop about blood pressure tracking?

The FDA issued a warning in July 2025 after Whoop released its Blood Pressure Insights feature without agency clearance. The agency stated the product was intended to provide blood pressure measurements or estimations.

According to the FDA, these specific functions are inherently associated with the diagnosis of hypertension and hypotension. Because of this link to medical diagnosis, the agency classified the feature as a medical device that required a formal review process.

Did You Know? In July 2025, the FDA formally warned Whoop that its Blood Pressure Insights feature required review because it provided estimations associated with diagnosing hypo- and hypertension.

How did Whoop respond to the regulatory warning?

Whoop contested the FDA’s classification, arguing the feature was designed for wellness purposes. The company maintained that the tool was not intended to treat or diagnose any specific disease.

CEO Will Ahmed stated that the company would not let “regulatory overreach” dictate how users access their own health data. Whoop argued the feature could be released without a formal review based on this wellness distinction.

Expert Insight: Samantha Carter notes that this dispute highlights the tension between consumer wellness data and clinical diagnostics. The stakes involve whether companies can provide health estimations to users without the rigorous clearance typically reserved for medical-grade equipment.

What may happen next for wearable health tech?

Whoop is likely to continue offering the Blood Pressure Insights feature now that the FDA has declined further enforcement. This may signal a period of stability for the current version of the tool.

Whoop says FDA is ‘overstepping its authority’ with warning about blood pressure feature

Future developments could include similar disputes over other wellness features. The agency may continue to monitor how wearable companies distinguish between “wellness” data and “medical” diagnosis in their product descriptions.

Frequently Asked Questions

What was the FDA’s primary concern with Whoop?
The FDA believed the Blood Pressure Insights feature acted as a medical device because it provided measurements associated with the diagnosis of hypertension and hypotension.

What is Whoop’s position on the feature?
Whoop, led by CEO Will Ahmed, argued the feature is for wellness purposes and not for treating or diagnosing diseases.

Is the FDA still taking action against the feature?
No. The FDA told Whoop last week that it would not take further enforcement action over the feature.

Do you believe health wearables should be regulated as medical devices or wellness tools?