Apple made a big deal of the ECG functionality of the Apple Watch Series 4, and emphasized that the feature had received FDA clearance.
It’s now being reported that the company was almost unable to do so – having received that clearance just one day before the launch event …
Fast Company reports the close call.
But at least one academic wonders whether that clearance should have been granted in the first place. Venkatesh Murthy, a cardiologist at the University of Michigan, has questioned Apple’s claims for the accuracy of the ECG feature.
I overheard an Apple employee talking about the near-miss in exasperated tones outside the Steve Jobs Theater just after the press event. I understood the man’s anxiety better when I saw that the FDA’s classification letters to Apple were dated September 11. Apple’s event was September 12.
Murthy told Health News Review that the study showing that the ECG feature had an accuracy rate of 98% in detecting AFib was potentially unreliable.
Murthy also expressed surprise that American Heart Association (AHA) president Ivor Benjamin effectively endorsed the feature by appearing on stage at the launch of the new Watch.
“The big problem with this conclusion is that this population has a prevalence of AFib that is probably 100-fold larger than Apple’s target market,” Murthy said. “This is not good. However, the major caveat here is that we are still lacking most of the information needed to be sure how this experiment was done.”
AliveCor also took issue with Apple’s claim that the Watch is the first over-the-counter ECG device to receive FDA clearance, noting that its KardiaBand won that prize. The company has responded to the launch of the Watch by announcing a much more accurate 6-lead reader.
Questions aside, there seems no doubt that the ECG feature is a key part of the appeal of the new model, many of today’s reviews referencing it as a reason to buy the new model.
