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Inside Blackstone · 2 min · Sep 15, 2026

WHOOP's FDA dispute hinged on whether its feature made a diagnosis

Will Ahmed recounts WHOOP's fight over its blood-pressure feature. He says the dividing line is whether a device gives a medical diagnosis, which can determine FDA oversight.

Will Ahmed

Will Ahmed is founder and CEO of WHOOP.

Founded WHOOP as a Harvard student; the health wearable tracks strain, recovery and sleep.

About this segment

Will Ahmed recounts WHOOP's fight over its blood-pressure feature. He says the dividing line is whether a device gives a medical diagnosis, which can determine FDA oversight.

From “WHOOP Founder Will Ahmed: The Body as Data, Sleep Science & the Future of Healthcare”, Sep 15, 2026. Watch the full episode

“if a product is not providing a medical diagnosis, the FDA actually should not be regulating it as a medical device.”
Will Ahmedat 15:31 · Inside Blackstone15:31

Takeaways

  1. WHOOP launched Blood Pressure Insights as a wellness feature.
  2. The FDA said measuring blood pressure made it a medical device.
  3. Ahmed argues wellness measurements differ from diagnostic features.

In this episode

Full episode
  1. 8:47Ahmed saw wearables bringing computers onto the body2:43
  2. 11:31WHOOP’s membership pivot turned engagement into recurring revenue2:39
  3. 16:47Ahmed says health AI’s advantage depends on access to data3:38

  4. 14:41WHOOP's FDA dispute hinged on whether its feature made a diagnosis2:19

Up next · The Pragmatic EngineerThe harness fills model gaps until training catches up4:45

Transcript

From the transcript Inside Blackstone publishes with the episode.

  1. 14:53

    Okay, so you recently had a dispute with the FDA, which again, kind of gets to this idea that you are becoming more of a sort of secret medtech company more than you are a fintech company. And I know you're good at this because you're gently weaving in all of these controversies. No, but they're so interesting. They speak to the fact that people are catching on to the fact that this is something so much bigger.

  2. 15:05

    Yeah. So the challenges with the FDA, in a sense, they began four years ago. We built Blood Pressure Insights, which was a wellness feature. We launched it alongside our WHOOP 5.0 and our WHOOP MG products. And, you know, immediately the FDA reached out with some concerns around it, citing that if a product is measuring blood pressure, it needs to be a medical device. Now, just to zoom out for a second, the way that the FDA operates is their mandate is to regulate medical devices that provide some kind of a medical diagnosis.

  3. 15:44

    And if a product is not providing a medical diagnosis, the FDA actually should not be regulating it as a medical device. So let's take heart rate, for example, if you're using heart rate monitoring for exercise, that's considered wellness. So the FDA is not going to regulate that. If you're going to do heart rate monitoring like ECG monitoring and tell someone they have AFib, okay, that's a medical diagnosis.

  4. 16:10

    The FDA is going to regulate that. And by the way, for WHOOP, we actually did both of those things. We did heart rate monitoring for exercise as wellness. And we actually worked with the FDA. And we have a medically cleared feature within WHOOP to do ECG monitoring that detects AFib. So we actually understand this framework really well. And so that was what we put out into the world. That's what we fought for.

  5. 16:31

    The FDA disagreed for a long time. They issued a warning letter. We disagreed with the warning letter. There was a lot of back and forth. There was some positive and negative media frenzy. And ultimately we won. And the FDA has since changed their guidelines, and I compliment them as well, because they recognize that technology is evolving, the world's evolving.