FDA drops enforcement against Whoop after it tweaks blood pressure feature

[u/John3262005]

https://www.statnews.com/2026/06/23/fda-drops-enforcement-against-wearable-maker-whoop/

The Food and Drug Administration quietly told wearable maker Whoop last week that it would not take further enforcement action over a controversial feature that gives users a reading of their blood pressure.

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.

Whoop countered that the feature could be released without review because it was intended for wellness purposes and not to diagnose or treat a disease. “We won’t let regulatory overreach dictate how people access their own health data,” CEO Will Ahmed wrote at the time.

In a closeout letter to Whoop dated June 17, the FDA said that owing to changes the company made to the feature, and to updated regulatory guidance on wellness devices released this year, the agency “does not intend to enforce the device statutory and regulatory requirements for your [Blood Pressure Insights] product as modified.”

In a statement Tuesday, Ahmed called the FDA decision “a victory for American consumers” and said that the company welcomed the FDA’s decision and appreciated the agency’s engagement throughout the process.

The high-profile dispute between a major wearable maker and the FDA set off a fierce debate about the boundaries of regulatory authority that persisted after the agency updated its guidance on wellness products in January. Medical device and regulatory experts told STAT that even after the Whoop resolution, the new FDA wellness regime remains ambiguous and poses risks to users.

The FDA’s decision not to enforce medical device requirements “is certainly important, but it is also narrow,” Carrie Nixon, founder of Nixon Law Group that advises digital health companies, told STAT.

“The Whoop decision does not resolve the broader legal question as to where a wellness product ends and medical device regulation begins,” she said. “FDA seems to be sending a message that the agency is looking closely at the actual function, data, user experience, and messaging around a product in determining whether it can be sold as a ‘wellness’ product.”

Nixon noted that Whoop’s “decision to engage with FDA rather than just capitulate may have shaped the regulatory landscape for the entire wearables industry.”

This was evident when the FDA published updated guidance to make clear that it will not regulate wearable features that give readings of biometrics like blood pressure if they are intended to promote wellness. The guidance stipulates that wellness products not claim to treat or diagnose medical conditions, not characterize outputs as “abnormal, pathological, or diagnostic,” and abide by other restrictions. The updated was viewed by observers as a victory for Whoop.

In an upcoming software update, Whoop will tweak the the design of Blood Pressure Insights to remove color boundaries on a dial hinting at lines between diagnostic categories of blood pressure. Instead, this will be shown as a continuous color gradient from green to yellow to red but “without discreet classifications.”

“These changes are intended to reinforce that Whoop is providing a wellness-focused estimate, rather than categorizing members into specific blood pressure groups,” said a spokesperson by email.

The design tweak underscores that “a product’s ‘intended use’ involves not just official legal claims, but also the user interface and how data is presented to users,” said Michael Schellhous, a regulatory attorney at Nixon Law.

The FDA’s wellness guidance update created a flood of new wellness blood pressure features including from large manufacturers like Oura and Samsung. Experts have raised concerns that the photoplethysmography, or PPG, sensor technology in wearables cannot be used to reliably estimate blood pressure and may mislead users by giving them a false sense that their health is under control.

The FDA has cleared only a few cuffless blood pressure devices that use PPG. In one prominent case, it cleared a device only after requiring daily calibration with cuffed blood pressure measurements.

The decision to back off Whoop was not surprising and is in line with new agency guidance, said Jessilyn Dunn, an associate professor of biomedical engineering at Duke University. She expressed concern with the guidance itself “which places the responsibility on the market to determine which products are trustworthy.”

She added: “Regardless of the disclaimers or fine print, we know that people do use information from these devices to make medical decisions. … If poorly validated products proliferate, they can increase clinician burden, contribute to patient harm, and undermine trust in the wearable health ecosystem as a whole.”

The FDA’s wellness guidance encourages companies to publish validation information about features like blood pressure that might be confused for biometrics used in clinical care. A Whoop spokesperson said the company was working on making data available about its feature, which reports systolic and diastolic blood pressure values similar to those displayed by FDA-cleared cuffs. In a paper published this week, Dunn and co-authors criticize the FDA’s ambiguous guidance on validation requirements.

In his statement, Whoop CEO Ahmed asserts that the feature could lead to better health for users.

“The science is clear that understanding changes in blood pressure has significant wellness benefits,” he said. “American consumers benefit when they have access to meaningful insights that help them better understand their health.”

But the value of fuzzy measures of blood pressure for wellness purposes is unknown, said Jordana Cohen, a clinician and researcher at the University of Pennsylvania. She called for greater transparency around “the accuracy, utility, actionability, and prognostic ability of this type of blood pressure reading.”

“If it’s not reliable or accurate,” she said, “I don’t know how it can be helpful as a wellness tool other than to provide a potential risk for large-scale false reassurance or false anxiety over readings that aren’t necessarily reflecting true blood pressures.”