The FDA just sent WHOOP a warning letter about our Blood Pressure Insights feature. Here’s why that’s misguided, why it undermines innovation in the United States, and why we’re not backing down.
Blood Pressure Insights by Whoop is a wellness feature. It gives members a daily estimate of their blood pressure range, based on passive, overnight data, to help optimize sleep, recovery, and performance. It’s accurate and non-invasive.
It does not diagnose any condition. It’s clearly labeled not for medical use. In fact, anyone accessing the app is required to go through an in-depth onboarding where they acknowledge that they know the device should not be used for medical purposes.
Here’s what’s frustrating: the FDA claims any display of blood pressure — regardless of disclaimers — requires medical clearance. That’s like saying your wearable shouldn’t show your heart rate because someone might think they have tachycardia if it’s too high.
Heart rate and respiratory monitors are regulated under 21 C.F.R. §§ 870.2300 and 868.2375, yet wearables can show that data for wellness. Blood pressure is no different. Peer-reviewed research confirms its relevance for wellness. There’s no reason to treat it differently.
Intended use is what matters - and the law agrees. The 21st Century Cures Act makes clear: Tools that support healthy lifestyles and don’t diagnose or treat disease aren’t medical devices. Blood Pressure Insights meets that standard.
We’ve gone above and beyond to design this feature responsibly:
-We tell members: this is not a medical device
-It does not diagnose hypertension or any other condition
-It accurately estimates your blood pressure range every day as measured
-We require members to proactively acknowledge that this device is not a medical feature
-It’s based on passive overnight trends - not clinical readings
We even invited the FDA to review the feature, the science, and the disclaimers. They declined to review all the details. Now they just want us to remove it. We are going to fight for our members’ access to their data.
To be clear, Whoop supports the FDA’s right to regulate medical devices. We spent years getting FDA clearance for our ECG feature that detects AFib. That’s a medical device. We follow the rules. Blood Pressure Insights, however, isn’t a medical device. And we won’t let regulatory overreach dictate how people access their own health data.
Worth noting, this is a US specific disagreement. Blood Pressure Insights by Whoop has been received favorably in 50+ markets around the world.
This isn’t just about Whoop. It’s about your right to understand your body and your health. It’s about giving Americans access to health and wellness data. We’ll fight this. Because the data can be measured accurately, and it belongs to you.
#wellness #innovation #regulation #freedom #whoop #fda
