On Tuesday, the Food and Drug Administration (FDA) warned fitness tech company, Whoop, over its new, unapproved, wearable blood pressure monitors, with Blood Pressure Insights (BPI) feature, declaring it an unregulated medical device.
Whoop’s $359-per-year “Life” subscription offers daily blood pressure (BP) estimated based on baseline cuff readings, but the FDA argues that diagnostic-like metrics risk misleading users, delivering potential dangers of inaccurate readings.
In its own defense, Whoop insists BPI is a wellness tool, such as heart-rate tracking. On its part, the federal agency is demanding compliance within 15 days, threatening severe penalties if the feature isn’t pulled or clinically validated.
The FDA’s scrutiny comes as tensions in the industry for wearable blood pressure monitoring keep expanding, where tech companies push the limits of monitoring health and regulators want to protect consumers.
Whereas Whoop says that BPI provides blood pressure insights to consumers, the FDA says the feature treads into medical territory that requires more stringent approval processes.
Science Behind Whoop’s Blood Pressure Insights
Whoop’s BPI estimates daily systolic/diastolic blood pressure ranges to better track performance and wellness. Members of the $359 “Whoop Life” can access these insights after submitting three traditional cuff-based BP readings to establish a baseline.
According to a Whoop spokesperson, the feature provides a single estimated value for a day, like ongoing measurements from continuous blood pressure sensors used in healthcare settings. They explain this distinction makes BPI more of a wellness device than a medical one.
The company also compares it with other wellness metrics tracked by fitness trackers with blood pressure monitor capability, such as heart rate variability and breathing rate and these are not medical devices that fall under regulation.
“We believe the agency is overstepping its authority in this case by attempting to regulate a non-medical wellness feature as a medical device,” Whoop spokesman stated.
Accuracy or Safety?
The FDA finds measurement of blood pressure a riskier function. However, in the warning letter, the agency noted that mistaken blood pressure results can create terrible health consequences if users make false assumptions about such results. The FDA pointed out that Whoop’s disclaimers do not change the fact that wearable blood pressure devices are designed to estimate blood pressure, which ties it into the diagnosis of diseases.
In an interview with CNBC, Dr. Ian Kronish, co-director of Columbia University’s Hypertension Center, stated that many health professionals are concerned about the accuracy of wearable devices monitoring biosignal like blood pressure.
At the same time, Kronish recognized the potential of such devices to help people manage their health but added that wearable data has to be shared with a healthcare professional.
Other companies, including Omron and Garmin, already offer FDA-regulated on-demand wearable blood pressure monitors. Samsung and Apple are currently developing or testing the same capabilities in their smartwatches, driving the growing blood pressure monitors market.
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