The FDA just sent WHOOP a warning letter about our feature, Blood Pressure Insights. Let me explain why this is a misguided move from the FDA and why it also undermines health and innovation in the United States. 🧵

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 that any display of blood pressure - no matter the use or the 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 monitors are regulated medical devices under 21 C.F.R. § 870.2300. Respiratory rate monitors are also regulated - under § 868.2375. But the FDA doesn’t stop wearables from providing heart rate or respiratory rate data for wellness use. Millions of people use that data every day.

Blood pressure is no different. There is no legal or scientific basis to treat it as a special case. Peer-reviewed medical research demonstrates that blood pressure has wellness implications. Therefore, just like heart rate and respiratory rate, blood pressure can support both medical and non-medical use. What matters is intended use. In fact, that’s the law.

We’ve gone above and beyond to label this feature responsibly. -We tell members: this is not a medical device -We require members to proactively acknowledge that this device is not a medical feature -It does not diagnose hypertension or any other condition -It accurately estimates your blood pressure range every day -It’s based on passive overnight trends - not clinical readings We stand by the feature's accuracy, which the FDA has not questioned.

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 critical role 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 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 for this innovation. Because the data can be measured accurately, and it belongs to you.