WHOOP CEO Defends Blood Pressure Insights Despite FDA Warning
The U.S. Food and Drug Administration recently flagged popular fitness wearable WHOOP, warning that its blood pressure software requires regulatory approval as a medical device.
WHOOP CEO Will Ahmed pushed back against the agency’s warning in a recent interview on CNBC’s Squawk Box, where he defended the company’s “Blood Pressure Insights” (BPI) feature.
This feature provides a daily estimate of a person’s blood pressure after performing a cuff calibration on the wrist.
- “There’s a pretty clear line of distinction for a number of physiological metrics. But for some reason, for blood pressure, the FDA says that there can’t be a wellness use case,” Ahmed said during an interview on CNBC.
Ahmed further clarified that the blood pressure feature is “pretty consistent” with the 21st Century Cures Act, which states that if a product or feature is intended for wellness and not related to diagnosis, cure, or prevention, it doesn’t need to be regulated by the FDA.
However, the FDA told WHOOP in a warning letter that measuring a user’s blood pressure is directly related to diagnosing hypotension and hypertension. Therefore, the purpose of the feature is to diagnose a disease or condition and potentially help in curing, mitigating, treating, or preventing it.
- “Although BPI provides a daily blood pressure range and midpoint measurement instead of a real-time reading, that is not sufficient to distinguish the product’s intended use from other blood pressure measurement devices,” the FDA wrote.
Providing blood pressure estimation is not considered a low-risk function by the FDA and requires more oversight than other features on a wearable.
- “High blood pressure is the most prevalent modifiable risk factor for cardiovascular disease in this country. Although traditionally blood pressure has been checked in a healthcare setting, ambulatory blood pressure checks are now in the American Heart Association (AHA) guidelines, and individuals are encouraged to check their own blood pressure at home. An erroneously low or high blood pressure reading can have significant consequences for the user,” the FDA continued.
Ahmed says he respects the FDA and has worked with them on various features before. But regarding BPI, he says, “they’ve got it wrong.”
Separately, Ahmed noted that WHOOP is among the first wearables globally to provide an accurate BPI estimate from the wrist. While this is a unique situation, the agency should support technology companies driving innovation.
- “This [situation] doesn’t actually deeply reflect the current administration as much as it does. What is the overall policy in the United States for innovation and for giving Americans access to health data?” said Ahmed.
In an email response to the Morning Chalk Up, the FDA said:
- “Patient safety is the FDA’s highest priority and is at the forefront of our work to protect and promote the public health. The FDA is responsible for ensuring that medical devices available in the U.S. meet the standards of safety and effectiveness.”
WHOOP has no plans to remove the BPI feature, according to an executive summary provided to Morning Chalk Up in response to a request for comment.
It plans to continue offering the wellness feature to consumers and encourages agency representatives to review it firsthand.
“We’ve overwhelmingly seen really positive support from our members on this feature. They’re getting accurate estimates every day. They love it. They seem to be in our court to fight this, and we’re going to continue fighting,” Ahmed said.
Featured image: WHOOP
