What you need to know
- A recent report states the FDA is going after Whoop over its Blood Pressure Insights feature present on its Whoop MG device.
- The FDA states Whoop should seek “prompt action” to rectify its lack of appropriate certification for the BPI.
- Whoop states its feature is more intended as a “wellness feature” and not as a “medical tool” as the FDA claims.
The Whoop MG is the company’s latest display-less tracker, but a recent report states it’s in hot water with the FDA.
In a report from Bloomberg, the publication states the FDA (U.S. Food and Drug Administration) is targeting Whoop for the removal of its Blood Pressure Insights (BPI), a feature the latter isn’t willing to budge on. According to the post, the FDA’s interest stems from the Whoop MG’s lack of certification for its blood pressure tracking capabilities. As such, the FDA reportedly told Whoop that it should seek “prompt action” to rectify this issue.
Bloomberg notes a statement from an FDA spokesperson today (Aug 13), which says the agency “has not authorized BPI for any use, including for the measurement or estimation of a user’s blood pressure.”
On Whoop’s side, the company says the FDA has “misinterpreted” its blood pressure estimation tool as a “medical tool.” More importantly, Whoop adds that its Blood Pressure Insights feature is labeled as a wellness-focused tool, and that it is not intended to diagnose more severe cardiovascular medical issues. The publication cites a letter written by Whoop to the FDA on August 4, which reads, “We believe it is not within the FDA’s authority to regulate the product. We therefore do not intend to remove the app.”
The post highlights Whoop’s intention to meet with the FDA, in hopes of having “a constructive dialogue” with its officials.
Wellness or Medical?
To expand on this, the Whoop 5.0 and Whoop MG launched earlier this year in May. The Whoop MG is the main highlight for this particular topic since it introduced the company’s Blood Pressure Insights. Per the company, the BPI feature is designed to provide “daily estimates of systolic and diastolic ranges right from your wrist.” Its launch post states these estimations may help users “understand your recovery, sleep, stress, and more.”
While Whoop’s fine print states its BPI is “not a medical device,” echoing its statement to the FDA, the agency continues to hammer home the fact that the device “does not fall under the general wellness device policy…”
Bloomberg highlights that the feature is only available for Whoop Life plan members, which costs a whopping $359 per year.
