WHOOP

Whoop made changes to its blood pressure insights feature that satisfied the FDA’s requirements for wellness devices.

Based on changes your firm has made to your “Blood Pressure Insights” product (“BPI”) and its labeling in response to our Warning Letter dated July 14, 2025, and consistent with the Food and Drug Administration’s updated guidance document, General Wellness: Policy for Low Risk Devices,1 FDA does not intend to enforce the device statutory and regulatory requirements for your BPI product as modified.

In July 2025, the agency warned Whoop for releasing its Blood Pressure Insights feature without clearance, saying it was a medical device that required review. “The product is intended to provide a measurement or estimation of a user’s blood pressure, which is inherently associated with the diagnosis of hypo- and hypertension,” the agency wrote in its warning letter.

The United States Food and Drug Administration (FDA) has learned that your firm is marketing Blood Pressure Insights (hereinafter, "BPI") in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (The Act). Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

Whoop received a warning letter from the Food and Drug Administration this summer after rolling out the blood pressure offering without regulatory authorization.

Whoop CEO Will Ahmed on FDA warning: Our blood pressure insight is intended for wellness use only

By Lauren Berg ( August 13, 2025, 11:02 PM EDT) -- Health and wellness company Whoop Inc., whose wearable devices track and collect users' heart rate, movement, blood pressure and other health metrics, is secretly sharing that data and other user information with an undisclosed third party, according to a proposed class action filed Wednesday in California federal court....

from AI, we're going to use it to cut jobs. We're going to get more efficient," Ahmed told journalist Ashwin Rodrigues for Inc. While those topics may be better suited for earnings calls, he says it's “wildly uninspiring for the workforce, and as a consequence, you see these remarkably low favorability ratings for AI.”  That view, he said, is underpinned by the $10.1 billion company’s 100 percent year-over-year growth.  “We view the market opportunity for health monitoring is huge and expanding, and there's a ton of things that we want to do,” he said.  Whoop itself is finding an equilibrium when it comes to AI. In March, Whoop announced that it planned to increase its headcount by hiring over 600 new employees. However, it has also moved to incorporate AI capabilities into its product, including an AI-powered coach, called WHOOP Coach, that utilizes its users biometric data, behavioral patterns, and environmental conditions to generate personalized recommendations. The startup also announced it would expand into AI-powered memory features, voice journaling, strength training progression, and medical records integration. “I think hiring and investing in talent and embracing AI tools is not a mutually exclusive strategy, just to say it. A lot of CEOs today are saying ‘we're leaning in on AI, so we're going to be letting people go,’ and I'm generally skeptical of that relationship, especially with the tools as they exist today,” Ahmed said.  He advised leaders who feel they aren't growing to look inward instead of blaming AI or their employees.  “These tools should be able to make us way more ambitious," he said. "And if we want to be more ambitious, that doesn't mean we want to let great people go. In fact, that means we want to find more great people and empower them with these tools.”

Whoop, a wearable technology company headquartered in Kenmore Square, anticipates it will hire more than 600 people over the course of 2026, approximately 80% growth in its headcount, according to CEO Will Ahmed.

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Total Spending $480K

Total Spending $480K

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