It's Friday, September 14th, 2018, and you're listening to Up to Date, our weekly recap of

Science in the News. Indrae is off this week. I want to talk about that Apple event and all of the

science claims that came out in regards to the Apple Watch. So the Apple Watch is going on sale,

and it's going to cost $18 killion dollars per every other Apple product. But

that's not what sort of caught my eye. What caught my eye was all of the discussion of health

claims, particularly about your heart rhythm and the ways they can better diagnose certain

conditions related to your heart rhythm and how they were talking about it.

They've always made some health claims that, like, the watch is going to help you monitor

your heartbeat, and that's going to lead to better results with your physician.

But now they've taken a step farther.

So Apple announced that now they have FDA certification on the Apple Watch. Let's unpack what that means.

So Apple applied for something called de novo certification. It's an FDA process that was

opened about 10 years ago. And this was really designed for medical devices that were coming

on the market that were relatively low risk for the end

consumer, meaning they pose no health risk to be used. So not like a medical stent that would be

inserted into your heart if you had like a bypass surgery or you needed to have an angioplasty.

Those are highrisk metal devices.

We need to assure they work.

So they have to go through rigorous FDA certification.

This is more like how a 23 and me would be certified, where as long as the information coming back to you is mostly right or accurate to a high enough

degree that, and you're encouraged to seek extensive medical help if you have sort of quote

unquote sort of positive results, they see this as a low risk venture. In fact, 23MME has this

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