Tim Cook says that the Apple Watch won't become a regulated medical device, but Apple might make another product that is. Cook made the comments earlier today in an interview with The Telegraph, stating that putting the Apple Watch through Food and Drug Administration testing would slow its release cycle down too much and "hold [Apple] back from innovating." That's something of a change in tone from what had been coming out of Apple prior to the Watch's releases, when word had it that Apple was working to outfit the wearable with all kinds of medical sensors.
"Maybe an app, maybe something else."
But Cook isn't moving away from Apple's health vision altogether. He tells The Telegraph that he "wouldn’t mind putting something adjacent to the Watch through" FDA testing. As for what that something is, Cook says, "You can begin to envision other things that might be adjacent to it — maybe an app, maybe something else." Products only need to be put through FDA testing if they're used to diagnose or treat a disease, which means that whatever Cook has in mind would have to do a lot more than track someone's activity and heart rate, like the Watch does today.
This is the first time that Apple has made it clear that the Apple Watch isn't going down a true medical track. Though the Watch clearly isn't there today, there remains speculation about Apple's work on health features. It likely can add some basic ones — "wellness devices" that simply encourage healthy habits aren't regulated by the FDA — but anything too advanced would have to go through a potentially time-consuming process that could require changes to the product or improving a technology before it can be sold. That would be a major issue for something like the Apple Watch, which is meant to be a mass market product that Apple can rely on year after year to boost revenues after a launch.
Cook also discussed the launch of the iPad Pro during the interview, taking a moment to trash its competitors. "I think if you’re looking at a PC, why would you buy a PC anymore?" Cook asks. "No really, why would you buy one?"