Apple CEO strongly hints at plans for an FDA regulated app or device

By Brian Dolan
10:06 am

Apple WatchBefore Apple revealed the Apple Watch, rumors circulated that because public records showed the company had met with FDA officials a few times, Apple was working on an advanced, sensor-laden wearable device with medical features that required FDA clearance. At the time, back in early 2014 I made the case that Apple was actually trying to ensure its wearable didn't trip a regulatory third rail and end up on the wrong side of the FDA -- the regulated side.

This week the company made clear that continues to be the plan for the Apple Watch, but it may have something else to send the FDA's way before long: This week Apple CEO Tim Cook told The Telegraph that while Apple won't be subjecting its watch to the 510(k) process, it may work with the FDA on some kind of regulated device, which could be an app, hardware, or a combination.

“We don’t want to put the watch through the Food and Drug Administration (FDA) process," Cook said. "I wouldn’t mind putting something adjacent to the watch through it, but not the watch, because it would hold us back from innovating too much, the cycles are too long. But you can begin to envision other things that might be adjacent to it -- maybe an app, maybe something else.” 

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Earlier this year the Wall Street Journal published a report that claimed Apple originally had far grander plans for its watch, which at various stages in its multi-year development included skin conductivity sensors, EKG sensors, blood pressure, and blood oxygenation. The report's sources claimed that the conductivity sensor displayed inconsistent readings in cases of hairy arms, dry skin, or when the watch was adjusted differently, while the blood pressure and SpO2 sensors sparked FDA concerns, in addition to being inconsistent.

Since Cook made clear to The Telegraph that Apple wasn't interested in creating an FDA-cleared version of the watch and that something "adjacent" to it might be a better way to go, it's possible -- and this is just speculation -- that Apple is working on a new band for the Apple Watch that has its own sensors built in, perhaps to track things like blood pressure or SpO2. Apple already sells various bands as accessories to the watch, so the product category already exists -- why not a regulated one? The band could go through the FDA process just like any number of other connected health devices.

Cook's remarks to The Telegraph are the first sure signs that the company is willing to move into regulated waters and not just help others in digital health working to launch medical-grade products.



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