I don’t own an Apple Watch. I do have a Fitbit. But the Apple Watch 4 announcement intrigued me in a way no other product has since the original IPhone.

This wasn’t just another product announcement from Apple. It heralded the U.S. Food and Drug Administration’s (FDA) entrance into the 21st century. It is a harbinger of the future of healthcare and how the FDA approaches innovation.

Sooner than people think, virtually all home and outpatient diagnostics will be performed by consumer devices such as the Apple Watch, mobile phones, fitness trackers, etc. that have either become FDA cleared as medical devices or have apps that have received FDA clearance. Consumer devices will morph into medical grade devices, with some painful and well publicized mistakes along the way.

Let’s see how it turns out for Apple.