CNBC's Brandon Gomez joins 'Squawk on the Street' to discuss FDA scrutiny over Whoop's blood pressure monitoring tech.

Washington

The US Food and Drug Administration (FDA) has sent a warning letter to wearable tech company Whoop, raising concerns about its new blood pressure monitoring feature. The FDA alleges that Whoop is marketing this feature without proper regulatory approval, as it may be used to diagnose or treat hypertension, which would classify it as a medical device.

Whoop argues that its blood pressure feature is intended to provide performance and wellness insights, similar to heart rate tracking, and is protected under the 21st Century Cures Act. The FDA, however, insists that the feature's intended use requires clinical testing and approval to ensure accuracy and prevent misdiagnosis. Whoop has 15 days to respond to the FDA's letter, and the outcome could set a precedent for other companies developing similar wearable health technologies.

Wearable tech draws FDA heat

The FDA sent fitness wearable company whoop a warning letter on Tuesday alleging the company's marketing its new blood pressure feature without proper approvals a Feature companies like Apple have been teasing for years now with the watch our Brandon Gobe is watching that story morning, Brandon Carl Yeah, the FDA has concerns over the feature that launched in May the crooks of the debate Intended use now whoop defends the BPI feature saying it uses blood pressure information to simply offer Performance and wellness insights similar to how more consumers are tracking their heart rate to improve health and performance Those features protected by the 21st century cures act which passed in 2016 to accelerate medical product development Now whoop says those protections apply here the FDA However saying the this innovation goes too far saying it is being used and marketed to diagnose cure treat or prevent disease in This case hypertension or high blood pressure now That's a key distinction that would reclassify the wellness tracker as a medical device and the FDA is concerned about misdiagnosis Whoop would need to go through FDA clinical trials and testing to certify the device's accuracy Whoop actually just went through that process with its ECG feature which detects potential heartbeat irregularities now Whoop has 15 days to respond to the FDA. I will tell you though Carl no signs of whoop backing down This is really about setting a precedent here Whoop says the FDA doesn't understand the broader wellness insights gained using blood pressure and developers will pay the price Apple has been teasing a blood pressure feature for its watch companies like Garmin and Amazon's or a ring could try something similar in the future to Carl Is this a matter of the technology? Evolving and getting better over time. Yeah, I mean that that's part of it, right? the the technology is definitely new and it hasn't actually been tested in terms of the The accuracy or how this applies to a wellness perspective, right? And so that's what the FDA is saying is that the research is not there They're trying to crack down and say look you need to have an FDA approved device the similar way you went through Sort of looking for heart murmurs or things like that in terms of the whoop features And so whoop is really the the first to market with this wrist Wearable that would be able to track this type of blood pressure measurement So why don't they just regulate it? I mean if it's gonna happen with Apple watches and all of these other wearable devices and well And so and that's what is that a big onerous process? And so that's what whoop is saying right now is that the FDA is in fact overstepping because they don't see this as a wellness Feature, but what they're arguing is this doesn't differ in the way that you would say use heart rate in order to track performance And wellness again all things that are protected under that 21st century cures act from back in 2016 Okay. Thank you, Brandon. Brandon Gomez

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