Apple's VP of Health Says Apple Has 'Good' Relationship With FDA, Will Continue to Do Great Work in the Health Space

[Firelock]

Bud, Apple didn't get FDA clearance for any hardware. Miniaturized, medical, or otherwise. They got clearance for software. Specifically for an ECG app.
And yes, I know you were referencing a smartwatch ECG function. Still disagree. Samsung is probably about to receive FDA clearance for a blood pressure function on a smartwatch. An equally impressive feat. There will be no fanfare. There will be no claim of Apple not innovating... well, beyond all the claims that already persist for other reasons. Apple gets an outsized amount of praise and they take an inordinate amount of criticism. Part and parcel of being Apple.

If you check out the article linked below it helps explain that the software validation is made contingent on the "anticipated conditions of use" which, now quoting the FDA document itself, includes "hardware platform and operating system requirements." What this in essence means is that the app is approved when used in conjunction with the Apple Watch and the latest WatchOS. https://brandwoodbiomedical.com/not...d-with-fdas-clearance-of-the-apple-watch-ecg/

 

[falainber]

Buddy up with Health Canada and get the ECG functionality working on the Series 4 please.

You really don't need Apple watch for this. Just buy one of the portable ECG monitors like this one. You'll probably get better results too.

 

[69Mustang]

If you check out the article linked below it helps explain that the software validation is made contingent on the "anticipated conditions of use" which, now quoting the FDA document itself, includes "hardware platform and operating system requirements." What this in essence means is that the app is approved when used in conjunction with the Apple Watch and the latest WatchOS. https://brandwoodbiomedical.com/not...d-with-fdas-clearance-of-the-apple-watch-ecg/

Are you attempting to prove an unrelated point here? You claimed Apple's achievements are downplayed, Samsung would be lauded for the same thing, and Apple would be accused of a lack of innovation. How does this support that? If you want to change the focus of the discourse, let me know. Cuz this has turned into a conversation about your supporting evidence, and not your original argument.

 

[Firelock]

Are you attempting to prove an unrelated point here? You claimed Apple's achievements are downplayed, Samsung would be lauded for the same thing, and Apple would be accused of a lack of innovation. How does this support that? If you want to change the focus of the discourse, let me know. Cuz this has turned into a conversation about your supporting evidence, and not your original argument.

No, that post was refuting your argument that the FDA clearance had no relation to hardware. And I note you didn’t have a response to that. My original point was that if another company had come out with this same innovation they would have gotten much greater attention for it, with their stock price being consequently awarded in a way that Apple's has never been given their ridiculous P/E ratio. Anyway, I’ve tired of this ridiculous back and forth so this is my last post on the subject. You can have the last word as I’m sure you will. It’s all yours.

 

[ChristianVirtual]

Great, now ask the PMDA or MHLW in Japan for approval ... with positive FDA should be easier.

 

[Piggie]

I have slipped on ice here in Minnesota twice and my "fall detection" did not go off. Yes, I checked to be sure it was turned on. Is there a way to adjust its sensitivity?

It's not the fault of the watch.
"You are not falling correctly"

 

[Morgenland]

Get DEXCOM & Apple Watch running. Core Bluetooth. Please.

 

[rjflyn]

Big $$ will come if they manage to be able to monitor blood glucose non invasivly with a relative level of accuracy. As it stands now the money in routinely monitoring at home is in disposable supply ie the test strips, at best if one test 3x day cheap is $1, = 365 year, insurance will be tripping over themselves to pay for a watch that saves $$ over time

 

[Marcus PM]

It's not the fault of the watch.
"You are not falling correctly"

I guess you are right. Next time I'll try landing on my watch and see if it responds.