| Whoop has said it trained its blood pressure model using data from over 11,000 members and then validated it against clinical readings. The company’s head of health care products Alex Vannoni recently said it was “highly accurate.” Representatives for the company did not respond to questions about whether performance data would be made public. A new noisy world There’s a broad feeling among industry observers that the FDA’s wellness guidance update would not have happened if Whoop hadn’t pushed the boundaries. Now patients, clinicians, and developers are left to navigate a new landscape. Brooke, the regulatory attorney, said it’s unfortunate that FDA created policies geared toward companies that want to avoid regulation, because there are many willing to do the hard work “to do things the right way,” he said. Cohen, who helped write the AHA scientific statement, said that even before blood pressure wearables were common, she found herself at loggerheads with a patient who insisted a watch purchased online showed normal blood pressure and that elevated readings in the office must be “white coat” hypertension that only shows up in medical settings. A 24-hour reading from an ambulatory blood pressure monitor showed alarming levels of hypertension. “My big concern is it’s going to create a bigger gap of physician distrust,” she said. Josep Solà, the co-founder and chief technology officer of Aktiia, said even in the wake of the updated FDA guidance, he believes it’s important for the company to remain focused on clinical applications of its cuffless technology. Still, he would not rule out a wellness offering. He said that the new products from well-known brands like Apple and Samsung help build credibility for his company. “The negative is that they’re adding a lot of noise to the market,” Solà said, “and more people will also come to the market with wellness things that just make nothing.” |