We wanted you to hear directly from us about an important update regarding Blood Pressure Insights and the U.S. Food and Drug Administration. Yesterday, the U.S. FDA asserted that they believe Blood Pressure Insights falls under the category of a regulated medical device in the USA. We disagree with this interpretation.
Here’s why:
Blood Pressure Insights was created to help members understand how blood pressure relates to sleep, stress, exercise, and recovery. To help you see patterns, make smarter choices, and improve how you live and train – not to diagnose or treat medical conditions.
Blood Pressure Insights is a wellness tool, not a medical one.
It’s designed to support informed lifestyle choices, not medical decisions.
It requires every member to acknowledge that they understand it’s not a medical device.
It aligns with the 21st Century Cures Act, which says that tools promoting healthy habits (and not involved in diagnosing, treating, or curing disease) are not medical devices.
Wellness features like this are common in wearable technology without requiring FDA review, like tracking your respiratory rate or HRV, and provide valuable insights to support you in making better decisions. Blood pressure is no different.
Blood Pressure Insights was built with rigorous data validation and peer-reviewed research on a model trained using over 32,000 sleep sessions from 11,000+ members. We stand by our accuracy, which the FDA has not questioned. We’re proud of the science behind the feature, and proud that so many members are already using it to find new connections between blood pressure and performance.
We support the FDA’s mission to regulate medical devices. In fact, we were proud to receive FDA clearance on our ECG feature to detect potential signs of atrial fibrillation, but we are also committed to bringing cutting-edge non-medical technology to empower you.
Here’s what you need to know as a member:
The FDA letter is relevant to the US market only, and Blood Pressure Insights remains available in all markets where WHOOP is sold.
If you’re on WHOOP Life, Blood Pressure Insights remains available in the WHOOP app. We still recommend regular calibration to keep it as accurate as possible.
We’re committed to giving you access to your wellness data and the tools to understand it (that hasn’t changed).
We stand by our promise to deliver wellness features that empower you to unlock your performance. We will fight to give you access to your own performance and wellness data.
I think it’s clear that BP measurements are just an insight and should not replace a Dr’s visit or use of a BP cuff. I find the BP to be quite accurate compared to my morning Cuff reading. But I do not like the Highest and Lowest reading added together and divided by 2. This is incorrect in my opinion and should be addressed ASAP. If you take 10 readings during the night and have 9 at 130 and one at at 100 you get 115 which is normal but the reality is it’s actually 130 x 9 + 100 / 10 = 127. Please consider a change and also show the actual readings and times. Adding the time will allow me to check my sleep to see if I was awake or sound asleep.
I respect the science in trying to make this a feature, but the fact that you regularly have to take BP readings with a real BP cuff - for a guesstimate on Whoop - kind of defeats the novelty. Just use the cuff!
Unless they’re a ticking time-bomb, people really don’t need to be obsessing about their BP every minute of the day.
The blood pressure news is disappointing. I subscribed to LIFE for the BP monitoring feature which I found not accurate (I put in dummy data which came back +/- 10 each day). Everything else is great. Can LIFE members opt down to PEAK?
I would like someone to answer my questions and explain the science behind the numbers. As you say you have to pump in actual numbers quite often so are they guesstimates. I am not surprised the FDA are questioning this.
As for a ticking time bomb we are all surely exactly that
My BP has been 115/70 most days and generally around the same with a BP cuff in the morning. But whoop shows I have highs of 125+, still not bad but I would like to know what is happening while I sleep and at what times.
So sorry to hear about this. I would much prefer if the FDA would just go away instead of getting in the way of health innovations. This is the device that I purchased and placed on my wrist, telling me the info that I want it to tell me. Why on earth does the FDA have any say in this?!?
I’m sorry the FDA is wasting your time and money, rather than staying out of your way and allowing you to focus on improving WHOOP and making it better and better. Wouldn’t it be nice if the government would help and assist progress rather than try to impede it?
If the FDA does prevail, please inform us how to change our WHOOP accounts over to be Canadian accounts so we can keep using this feature. Thanks.
Hi @AlanGooner, thank you for the nice words. Regarding the reading itself, WHOOP doesn’t generate a blood pressure estimate by averaging individual high or low estimates; therefore there are no time stamps of individual readings. Instead, we generate a morning blood pressure estimate based on a comprehensive analysis of your sleep data, heart rate, HRV, respiratory rate, and other overnight biometrics. We appreciate the feedback as always, and I’ve passed on this feedback to the team.
Whilst I totally understand that this is not a medical device and should never replace a Drs visit or a BP Cuff. I am really struggling with what I am seeing. Personally if you are doing some sort of estimate then I think I would simply prefer to see a number for Systolic and Diastolic and not see high & low ranges, this suggests you actually measured during the night. Well at least for me it suggests that.
Again this is not a medical device and me with normal BP it’s not an issue, I check my BP in the morning and it is close to the numbers I am seeing. But what about users that don’t have great BP and are seeing highs that could be disturbing.
I am just puzzled by what I am seeing and apologies to keep harping on about it
Hi @AlanGooner, I’ll have a member of the Membership Services team reach out. Might be easier for your specific case for me to get you in touch with a member of the team. Stay tuned.
BP monitoring is considered a medical device due to monitoring a medical condition (BP). Whoop measures BP, ECG, and pulse oximetry which all fall under the medical device regulations. Hopefully, Whoop will remedy the agency’s concern as this brings the validity of other data points measured into question.
Thanks @leslievp. WHOOP fully respects the FDA’s role in regulating medical devices and has demonstrated this through our multi-year effort to secure a 510(k) clearance for our ECG feature. However, we believe the agency is overstepping its authority in this case by attempting to regulate a non-medical wellness feature as a medical device.
It’s obvious you’re selling the illusion of a medical tool. No scientific rigor – just flashy language and algorithmic guesses.
If even basic blood pressure monitors differ in accuracy, then what can be said about your non-validated predictions? This isn’t innovation – it’s medical optics for marketing, dressed up as innovation.
There are already FDA-cleared devices like Huawei that provide actual BP tracking. Meanwhile, WHOOP looks like it’s selling vaporware with a subscription.
Judging by your updated Terms of Use – where you waive all responsibility – it’s obvious you’re fully aware that your “insights” won’t hold up under real scrutiny.
As someone who bought WHOOP MG, I can say with full confidence: the BP “insight” is pure placebo. There is no meaningful difference between WHOOP MG and 5.0 — except for the inflated price tag and the marketing narrative built around it.
You’re selling the feeling of medicine, without any of the responsibility. That’s exactly why the FDA is now calling you out. And they’re right to do so, in my opinion.
