Doesn’t the FDA do harm by requiring that Apple watch blood pressure monitor be equal in accuracy to a standard clinical blood pressure monitor? Many people will not take the time and effort to get frequent readings from a standard blood pressure monitor in a clinic. But many of them would check their blood pressure conveniently on their watch. Isn’t a less accurate reading better than no reading at all?
(p. A1) Apple’s widening effort to turn its nine-year-old watch from a luxury timepiece into the ultimate all-in-one medical device is taking it into territory that is legally treacherous as well as potentially profitable.
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(p. A2) “The studies that we’ve seen are not yet reassuring that they’re ready for prime time or for clinical use,” said Jordana Cohen, associate professor of medicine and epidemiology at the University of Pennsylvania.
To secure Food and Drug Administration clearance for selling a blood-pressure monitor, companies must demonstrate through the FDA’s 510(k) process that their device’s accuracy is comparable to an existing, already cleared device, she added.
Similarly, tracking glucose through noninvasive skin sensors is generally less precise than direct blood analysis, with factors such as skin tone and temperature affecting accuracy.
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(Note: ellipsis added.)
(Note: the online version of the story has the date December 28, 2023, and has the title “Apple Keeps Chasing the Ultimate Health-Tracking Watch—but It Could Take Years.”)