Latest news with #WhoopInc
Al Arabiya
2 days ago
- Health
- Al Arabiya
Whoop refuses to disable blood pressure tool despite FDA warning
Whoop Inc., the maker of screen-less fitness bands, said it will not disable its blood-pressure tracking tool despite a request from the US Food and Drug Administration. The FDA last month sent a warning letter to Whoop stating that the company's Blood Pressure Insights feature, or BPI, which both measures blood pressure and provides related feedback, means that the Whoop is operating as a medical device. The new Whoop MG — short for medical grade — doesn't have such certification for blood pressure tracking despite intending to 'help with the diagnosis, cure or treatment of a disease,' according to the government agency. The band launched in May with the feature as a central addition. Whoop pushed back on the FDA's warning in a letter to the agency dated Aug. 4. 'We believe it is not within the FDA's authority to regulate the product. We therefore do not intend to remove the app,' the company wrote. 'We will continue to offer the wellness feature to consumers.' It added in a statement that it has 'requested a meeting with the FDA and hopes to have a constructive dialogue with agency officials.' On Thursday an FDA spokesperson said the agency 'has not authorized BPI for any use, including for the measurement or estimation of a user's blood pressure,' adding that 'patient safety is the FDA's highest priority.' FDA Versus Tech The FDA has clashed periodically over the last dozen years with technology companies whose devices the agency believes need regulation because they constitute medical advice. Still, Whoop's defiant reaction is rare. While regulators have struggled to define exactly when the line from wellness to medical advice is crossed, tech firms have often taken offending products off the market and sought FDA clearance or tweaked their product to comply. Meanwhile, consumer hardware makers have been adding more sophisticated health tracking tools to their fitness bands and smartwatches, blurring the lines between a wearable gadget and medical device. While the FDA can impose injunctions and fines on companies that fail to comply with violations raised in warning letters, it's rare that it follows through. The agency initially told Whoop that it should take 'prompt action' to address any violations or face potential regulatory action, including seizure, injunction and civil monetary penalties. The FDA also told Whoop it could go through the normal device approval process, something that Whoop doesn't want to do given the long amount of time that could take. Whoop said in its response that the feature is labeled for wellness purposes, not for diagnosing or treating medical conditions like hypertension. Whoop also said that repeated disclaimers are provided during the sign-up process. It characterized the issue as a 'misinterpretation' by the FDA, saying the agency views blood pressure estimation as a medical tool. The 'FDA's assertions fail to account for the substantial and growing body of scientific evidence supporting non-medical uses of blood pressure as well as the actual use of blood pressure information by the feature,' the company said in its response, which was provided to Bloomberg News. The Blood Pressure Insights feature lets users get a daily estimate of their blood pressure range so they can better understand the impact on overall health and athletic performance. The tool is available only to subscribers of the $359-a-year Whoop Life plan. The feature requires an initial calibration with a standard blood pressure cuff. Whoop Chief Executive Officer Will Ahmed previously called the FDA's letter 'misguided' on social media. The FDA said the product does not fall under the general wellness device policy because blood pressure it is not a low-risk use case. 'An erroneously low or high blood pressure reading can have significant consequences for the user,' it said in its July letter to the fitness startup. During an interview with Bloomberg TV on Thursday, Ahmed said he believes the company will be on the 'right side of history' and fighting for Americans' access to health data is the 'right thing to do.' 'Ultimately, innovation needs to be built to thrive in the United States,' he said. 'We're one of the first wearables that can measure blood pressure accurately on the wrist. That's a big deal. We want to make sure that there are policies that are consistent here in the US that really allow companies to innovate and to operate.' Other companies such as Garmin Ltd. offer FDA-cleared blood pressure reading tools. It's a feature also available on smartwatches from Samsung Electronics Co. Health and Human Services Secretary Robert F. Kennedy Jr. has promoted the use of wearable fitness devices. In an appearance before Congress in June, he said his vision is for every American to be using a wearable device within four years. Whoop CEO Ahmed was pictured meeting with Kennedy and other health tech companies in May.
Bloomberg
3 days ago
- Health
- Bloomberg
Whoop Refuses to Remove Blood Pressure Tool Despite FDA Warning
Whoop Inc., the maker of screen-less fitness bands, said it will not disable its blood-pressure tracking tool despite a request from the US Food and Drug Administration. The FDA last month sent a warning letter to Whoop stating that the company's Blood Pressure Insights feature, which both measures blood pressure and provides related feedback, means that the Whoop is operating as a medical device.
Bloomberg
09-05-2025
- Business
- Bloomberg
Whoop Faces Backlash After Charging Existing Users Upgrade Fee for New Models
Whoop Inc., the maker of popular screen-less fitness bands, is facing a backlash from subscribers upset that it's charging an upgrade fee for the new models after previously pledging not to do so. The company on Thursday unveiled two new fitness bands, the Whoop 5.0 and MG, which add improved sleep tracking and new features like blood pressure monitoring in the higher-end model. The company's business model charges users an annual subscription — ranging from $199 to $359 a year — versus an upfront payment for the hardware.
