FDA clears WHOOP blood pressure feature after year-long standoff

FDA ends WHOOP blood pressure standoff with closeout letter

The US Food and Drug Administration has formally closed its enforcement action against wearable fitness company WHOOP over its Blood Pressure Insights (BPI) feature, issuing a closeout letter that ends a dispute that had dragged on for more than a year. The resolution, confirmed this week after WHOOP chief executive Will Ahmed announced it publicly on LinkedIn, marks one of the most significant regulatory moments in consumer wearable health technology in recent memory.

In its closeout letter to WHOOP, dated June 17, 2026, the FDA stated:

"Based on changes your firm has made to your 'Blood Pressure Insights' product 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, FDA does not intend to enforce the device statutory and regulatory requirements for your BPI product as modified."

The letter is explicitly limited in scope: it applies to Blood Pressure Insights as modified and does not extend to other WHOOP features or any future changes the company might make.

How the standoff began

The dispute originated in July 2025, when the FDA's Center for Devices and Radiological Health issued Warning Letter CMS #709755 directly to Ahmed as CEO of WHOOP, Inc., based in Boston. The agency argued that WHOOP was marketing Blood Pressure Insights in the United States without the required marketing clearance or approval, characterising the feature as a medical device.

"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 FDA wrote at the time. The agency noted that WHOOP had marketed BPI as a "medical-grade" offering capable of delivering daily systolic and diastolic blood pressure estimations — language that, in the regulator's view, tipped the feature firmly into medical device territory requiring premarket approval.

WHOOP refused to remove the feature. The company argued that BPI was a wellness tool, not a diagnostic one, and Ahmed was publicly combative: "We won't let regulatory overreach dictate how people access their own health data," he wrote during the dispute. The company and the FDA remained at an apparent impasse for months.

The regulatory shift that broke the deadlock

The resolution came through two parallel moves. WHOOP modified its product and labelling, and the FDA updated its own guidance. On January 6, 2026, the agency finalised a revised version of its General Wellness: Policy for Low Risk Devices, which departed significantly from its mid-2025 position. The updated policy clarified that products measuring physiological parameters — including blood pressure — may qualify as general wellness products rather than medical devices, provided they meet specific conditions.

Under the updated guidance, a blood pressure feature can avoid medical device classification if it is noninvasive, does not involve technology that poses a safety risk, is not intended for diagnosis, cure, mitigation, prevention or treatment of disease, does not guide clinical management, and does not produce outputs that mimic clinical values unless validated.

WHOOP's modifications to BPI were designed to bring the feature in line with those conditions. In an upcoming software update, the company will redesign the feature's interface to remove colour-coded boundaries on a dial that previously hinted at diagnostic categories of blood pressure — a visual cue the FDA regarded as clinically suggestive. WHOOP's product page now also carries explicit wellness-only disclaimers, stating that Blood Pressure Insights is "not a medical device and cannot diagnose or manage medical conditions," does "not provide medical advice," and is "not intended for use if you are pregnant or on blood pressure medication."

What Ahmed said

Writing on LinkedIn following the closeout letter, Ahmed struck a notably different tone from his combative stance of 2025:

"When the FDA first issued the warning letter, many experts advised Whoop that removing the feature was the only path forward. But we believed in the strength of science and our responsibility to the members who rely on it. That conviction guided our approach throughout this process."

He added that the company had "consistently made clear" that Blood Pressure Insights was a wellness feature with appropriate safeguards and disclosures, and said WHOOP looks forward to working with the FDA as it brings more regulated medical technologies to market. Ahmed described the regulatory update as a "major development."

How the WHOOP MG and Blood Pressure Insights work

Blood Pressure Insights is available on WHOOP's Life membership tier and sits within the WHOOP MG device — a wrist-worn tracker offering a 14-day battery life in a form factor seven per cent smaller than its predecessor. The device also features an on-demand ECG, atrial fibrillation detection, and a Healthspan metric that produces a WHOOP Age score.

The blood pressure feature works by using the device's sensors to measure heart rate, heart rate variability (HRV), and blood flow patterns during sleep, generating systolic and diastolic range estimates upon waking. Users must log traditional cuff readings in-app to calibrate their baseline before the feature unlocks — a step that underlines its wellness, rather than clinical, positioning.

In the United States, the WHOOP Life membership — which includes the MG device — is priced at $359 per year. No UK sterling price or confirmed UK launch date for Blood Pressure Insights has been verified. WHOOP notes that features such as ECG and irregular heart rhythm notifications depend on regulatory approval in each country. UK buyers should confirm regional availability directly with WHOOP before purchasing.

What the industry is watching

Industry observers have widely described the outcome as significant beyond WHOOP itself. The FDA's updated General Wellness policy now establishes a clearer framework for the entire wearable sector: the regulatory test for health metrics is intent and interface design, not the measurement category alone. For companies developing advanced biometric features — from continuous glucose indicators to sleep apnoea flags — the WHOOP case offers a template for how to structure a wellness product that avoids triggering medical device requirements. Whether UK and European regulators move in a similar direction remains to be seen.