In a bold stand against federal oversight, Boston-based wearable tech company Whoop is refusing to comply with the Food and Drug Administration’s (FDA) demand to regulate its Blood Pressure Insights feature as a medical device. The FDA, in a July 2025 warning letter, insisted that the feature, introduced in May on Whoop’s fitness-tracking wristband, requires approval due to its association with diagnosing conditions like hypertension. Whoop, however, maintains that the tool is a wellness feature, not a medical device, and has vowed to continue offering it without submitting to regulation.
Whoop, founded in 2012 by Harvard alum Will Ahmed, has grown into a $3.6 billion enterprise, backed by high-profile athletes like Cristiano Ronaldo, Aryna Sabalenka, and Patrick Mahomes. Its wristband tracks metrics such as heart rate, sleep quality, and, with the new Blood Pressure Insights, estimated blood pressure. The FDA argues that this feature, by measuring a metric “inherently associated” with diagnosing diseases, falls under its jurisdiction as a medical device, similar to traditional blood pressure cuffs. The agency warned that Whoop’s continued distribution without approval violates federal law, potentially leading to penalties like product seizures or fines.
In a defiant August 4, 2025, response shared with The Boston Proper, Whoop rejected the FDA’s stance, leaning on the 21st Century Cures Act of 2016, which exempts wellness-focused software from medical device classification if it does not diagnose, prevent, or treat disease. The company insists Blood Pressure Insights is designed to inform users about performance, sleep, and stress, not to diagnose medical conditions. Whoop further aligned its position with Health and Human Services Secretary Robert F. Kennedy Jr.’s goal of reducing regulatory barriers to foster innovation, arguing that the FDA’s push contradicts this vision.
Legal experts view Whoop’s resistance as a high-stakes gamble. “Defying the FDA is rare and risky,” said Chris Robertson, a Boston University law professor specializing in FDA regulations. “A warning letter usually prompts compliance, so Whoop is playing with fire.” Frances Miller, another BU health law expert, drew parallels to the FDA’s 2013 clash with 23andMe, which ultimately complied after a similar dispute over its genetic health tests. However, Miller noted that recent budget cuts to the FDA under the Trump administration and Kennedy’s pro-wearable stance—aiming for universal adoption within four years—may weaken the agency’s leverage.
The dispute highlights the murky regulatory landscape for wearable technology, a market valued at $84 billion in 2024 and projected to grow rapidly. Unlike competitors Apple and Fitbit, which have sought FDA clearance for features like ECG monitoring, Whoop has only registered its Heart Screener tool for detecting atrial fibrillation. The company’s refusal to regulate Blood Pressure Insights could set a precedent for how wellness devices are treated, especially as Kennedy pushes for broader wearable access.
As the wearable industry races to innovate, Whoop’s standoff with the FDA raises critical questions about balancing consumer access with safety oversight. With no resolution in sight, the outcome could reshape the future of health tech regulation.
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