Boston-based wearable fitness company WHOOP has come under scrutiny from the FDA for its Blood Pressure Insights feature, which the agency claims is being marketed improperly without proper regulatory approval.
In a letter to WHOOP, the FDA states BPI qualifies as a medical device under federal law as it provides daily estimates of systolic and diastolic blood pressure, which the agency says are "inherently associated with the diagnosis of hypo- and hypertension, and is therefore intended for use in the diagnosis of a disease or other condition, or in the cure, mitigation, treatment or prevention of disease."
The agency says it has not authorized BPI for any use, and WHOOP has neither premarket approval nor 510(k) clearance for BPI. It also states WHOOP failed to notify the FDA before distributing the product, making the device both adulterated and misbranded.
Following receipt of the letter, WHOOP issued a statement saying it disagrees with the FDA's claims and that BPI is a wellness feature, not a medical device.
"It's designed to help you understand how your body responds to daily life, not to diagnose or treat any condition. Wellness features like this are common in wearable technology, like tracking your respiratory rate or HRV, and provide valuable insights to support better decisions about your performance without requiring FDA clearance," WHOOP said in a statement.
In the FDA's letter, however, the agency stated that even if WHOOP's BPI were intended solely to support general health, it would still not qualify under the FDA's general wellness policy, as blood pressure estimation is not a low-risk function.
"High blood pressure is a leading, modifiable risk factor for cardiovascular disease, and home monitoring is now recommended in AHA guidelines, making accuracy critical," the agency wrote.
The FDA's letter states that WHOOP had a call with the agency, during which it indicated its intention to continue marketing BPI without FDA authorization, despite the FDA's assertion that the product is a medical device and requires approval to be legally marketed.
"Your firm should take prompt action to address any violations identified in this letter," The FDA wrote. "Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice."
The agency warned that possible regulatory action, including seizure, injunction or civil penalties, may be taken if WHOOP does not address the violations within 15 business days from the date of the letter.
THE LARGER TREND
In 2020, WHOOP earned unicorn status after closing a $100 million Series E funding round, bringing its valuation to $1.2 billion.
Less than a year later, the wearable tech company raised $200 million in Series F funding, bringing its total raise to $400 million and boosting its valuation to $3.6 billion.
Another company in the wrist wearable blood pressure monitoring space is Aktiia, which earlier this month announced it received FDA 510(k) clearance for its cuffless, wrist-worn blood pressure monitor, G0 Blood Pressure Monitoring System, also known as the Hilo Band.
The wearable, which already secured CE mark in Europe, uses optical sensors and pulse wave analysis to estimate blood pressure when the wearer is at rest. The company said the wearable will be available to U.S. consumers in 2026.
