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

[MoreRumors?]

The approval Apple got is "informational only", it's not a medical device. But the information seemingly spurs people to go to doctors, as appropriate, and get a sound medical opinion. The watch isn't supposed to render a medical diagnosis. But people are claiming the "information" spurred them to go to a doctor.

I believe you are correct. The FDA website does not list the watch as an approved device and I looked at 2017, 2018 and current year. At the Press Statement, it explains about the Apple app and it was the only thing I can find.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620246.htm

While it is a unique device to measure your vitals, hopefully it will spur the individual to maintain and continue a regular excercise routine and having a healthy eating habit.

 

[I7guy]

If Apple had obtained FDA approval its stock would indeed have gone through the rough. But it didn't, so there you go.
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The FDA did not approve anything. What Apple received was clearance to sell the device.
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The article (if you actually read it rather than just the headline) states "the company has received FDA clearance for both an atrial fibrillation-detecting algorithm and an ECG that will be built into the new Apple Watch Series 4"

The headline is incorrect. The text of the article is correct. Approval and clearance are not the same thing.
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Who said it isn't there? A good relationship doesn't mean Apple can ignore laws, or that a country will look the other way when a company does.
[doublepost=1550888178][/doublepost]

Apple's stock is down nearly 30% from its high and trading at barely 10 times earnings. That is most definitely not "through the roof." Toilet is more like it.

Yes, the watch received a class II de novo clearance.

https://www.theverge.com/2018/9/13/...es-4-ekg-fda-approved-vs-cleared-meaning-safe

 

[69Mustang]

I believe you are correct. The FDA website does not list the watch as an approved device and I looked at 2017, 2018 and current year. At the Press Statement, it explains about the Apple app and it was the only thing I can find.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620246.htm

While it is a unique device to measure your vitals, hopefully it will spur the individual to maintain and continue a regular excercise routine and having a healthy eating habit.

The problem is a lot of people are conflating FDA Clearance with FDA Approval. They are not the same. Apple has FDA Clearance. The media isn't helping because they aren't mentioning the distinction. They also aren't mentioning the restrictions on Apple's FDA Clearance. I'm betting most don't know that people under 22 years of age aren't supposed to use Apple's new features. I'd also bet that most don't know that the features aren't recommended for people who already have arrythmia's.

Apple has the opportunity to do some major good. They have to be transparent though because all that good can be ruined by lack of transparency. Just a hunch, but I bet that under 22 thing will throw a lot of people for a loop.
Apple's actual FDA Clearance letter. Prohibitions are on the first page.
https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180044.pdf

 

[ipedro]

Fall detection goes off A LOT when I am playing soccer and I save a hard strike in goal. It's not easy to take your gloves off to prevent it from calling 999 mid match. Hope they can sort this.

If your role in sport is to fall on purpose, then maybe turn off fall detection?
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Buddy up with Health Canada and get the ECG functionality working on the Series 4 please.

You’ll be waiting a while. Health Canada hadn’t even received an application from Apple as of December.

https://twitter.com/GovCanHealth/status/1071067627643133952?s=20

 

[MauiPa]

It's great that Apple is focusing on the health aspects of tech. But if today's news about apps sharing customer data with Facebook isn't a warning, it definitely should be. Especially since a couple of those apps were health related.

You would think we had the ability to see companies like FB for doing this, particularly when they are violating the terms of the agreement for using the apple store. Who gets to hold FB and others accountable?
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If any other company had gotten FDA approval for a wristwatch that serves as a portable ECG, their stock would have gone through the roof and the media would not stop talking about it. Apple does it and everyone yawns and asks, “where’s the innovation?”

instead of jumping on the haters bandwagon, technically it is not FDA Approval, it is something like "clearance". Not sure the difference is explained anywhere and most people won't care about the distinction. But there do seem to be a lot of people calling you out, for what is simply semantics.

Can't wait to see Samsung's approval process of their vaporware feature of blood pressure monitoring from a watch. Unless it is using a cuff that talks to the watch, this could be groundbreaking. I already use a cuff that sends to my iPhone (not sure why I would want it to send to the watch). Wrist monitors are not too accurate, so I doubt they simply added a cuff to the watch band. Can't wait to see it and how accurate it is.

 

[69Mustang]

You would think we had the ability to see companies like FB for doing this, particularly when they are violating the terms of the agreement for using the apple store. Who gets to hold FB and others accountable?
[doublepost=1550934413][/doublepost]

instead of jumping on the haters bandwagon, technically it is not FDA Approval, it is something like "clearance". Not sure the difference is explained anywhere and most people won't care about the distinction. But there do seem to be a lot of people calling you out, for what is simply semantics.

Can't wait to see Samsung's approval process of their vaporware feature of blood pressure monitoring from a watch. Unless it is using a cuff that talks to the watch, this could be groundbreaking. I already use a cuff that sends to my iPhone (not sure why I would want it to send to the watch). Wrist monitors are not too accurate, so I doubt they simply added a cuff to the watch band. Can't wait to see it and how accurate it is.

Samsung's approval process will probably be very similar to Apple's. Expedited for FDA Clearance, not FDA Approval. Samsung's BP feature isn't vaporware. It's set to go live in 5 countries in a couple of weeks. It's not a pressure cuff like Omron's Heartguide. It's app based just like Apple's feature. It took Apple about a month to get approval. I'd imagine Sammy would take just as long with the new streamlined process.
https://www.wareable.com/health-and-wellbeing/apple-fitbit-samsung-fda-health-pilot-fast-track-3311

 

[GadgetBen]

You can turn it off.
https://support.apple.com/en-us/HT208944

No thanks, I want it switched on but working for the purpose it is meant to serve.

 

[ipedro]

No thanks, I want it switched on but working for the purpose it is meant to serve.

So your sport involves you falling on purpose but you don’t want it to detect that, only when you fall by accident? Ok... we’ll let you know when Apple releases mind reading technology. Have a seat, it’ll be a bit of a wait.

 

[GadgetBen]

If your role in sport is to fall on purpose, then maybe turn off fall detection?
[doublepost=1550932333][/doublepost]

You’ll be waiting a while. Health Canada hadn’t even received an application from Apple as of December.

View attachment 823232

https://twitter.com/GovCanHealth/status/1071067627643133952?s=20

I’m not falling when it goes off I’m just catching the ball standing up. Otherwise I would not have commented about it.

 

[69Mustang]

I’m not falling when it goes off I’m just catching the ball standing up. Otherwise I would not have commented about it.

Isn't fall detection based on rapid acceleration then deceleration and directional change detected by the watch's accelerometer and gyroscope? If it is, there's really nothing Apple can do. Catching a fast moving ball mimics the same characteristics of a fall, rapid accel/decel of the arm wearing the watch.

 

[BuddyTronic]

Fall detection goes off A LOT when I am playing soccer and I save a hard strike in goal. It's not easy to take your gloves off to prevent it from calling 999 mid match. Hope they can sort this.

You can adjust the settings for this so it will wait a minute and see if you are not moving before it makes the call. Did you realize that?

 

[TVreporter]

If only the slow-as-flowing-syrup Canadian government could give this approval. Health Canada takes forever to review and approve anything.

It’s one main reason I’ve been hold out on getting the watch. I want to utilize it to its max.

 

[Piggie]

If any other company had gotten FDA approval for a wristwatch that serves as a portable ECG, their stock would have gone through the roof and the media would not stop talking about it. Apple does it and everyone yawns and asks, “where’s the innovation?”

Edit: Should have said "clearance" instead of approval. Substance of the post still stands.

Please correct me if I'm wrong, but it was not that Apple got FDA approval as such, but the FDA had to create a new category in order to approve the Apple watch.
It would not have passed approval otherwise.

 

[NovemberWhiskey]

Call me crazy, but I'm against companies having any sort of relationship with the FDA

 

[npmacuser5]

Maybe because the Watch is usually crying wolf

And you know this how? I am an Apple Watch user from Watch 0. The watch has been extremely accurate in my situation. Nailed my issue better then the 10 minute ECG in the clinic. So accurate, caused the doctor to order extensive montering by a $2,800 ECG monitor. At the end of the extended tests, the Apple Watch in perfect sync with the medical grade device.

The Apple Watch advantage over an in doctor’s office device, all day everyday monitoring. The heart early symptoms are usually Very random. Mine happened at random times over a period of weeks. Very hard to detect with an office visit. Without the Apple Watch Data, I would have been sent on my merry way with No further testing.

The Apple Watch collects data, taps you if data out of normal, Does Not Diagnose Anything. The crying wolf, since Apple Watch 0, not happend to me ever.

 

[truthertech]

A lot of confusion over what "approval" means. In this case, the more accurate term is "cleared." Even more important is what level of device the ECG monitor on the AW falls under-- A Class 2 device.

"Most of the time, products are cleared because they’re sufficiently similar to an existing medical device that the FDA already regulated. Apple, however, has emphasized that it has received a “de novo” classification for the EKG feature. That means that, although it’s still in Class II in terms of risk and hasn’t gone through as much testing as an “approved” device, it’s unlike anything else on the market. It is the first direct-to-consumer EKG wearable. (Last year, the FDA approved the AliveCor KardiaBand, a watch accessory that essentially does the same thing, but that wasn’t direct-to-consumer.)"

For more details:

https://www.theverge.com/2018/9/13/...es-4-ekg-fda-approved-vs-cleared-meaning-safe

 

[Firelock]

You would think we had the ability to see companies like FB for doing this, particularly when they are violating the terms of the agreement for using the apple store. Who gets to hold FB and others accountable?
[doublepost=1550934413][/doublepost]

instead of jumping on the haters bandwagon, technically it is not FDA Approval, it is something like "clearance". Not sure the difference is explained anywhere and most people won't care about the distinction. But there do seem to be a lot of people calling you out, for what is simply semantics.

It's the price for posting on MacRumors. I’ve corrected my error, but I think the substance of my post still stands, which is it is a significant advancement that will have and has already had a positive impact on people's lives. And it is reliable enough that the FDA has cleared it. Had this been done by Samsung people would have been asking why Apple isn’t innovating the same way.

 

[twinlight]

Seeing how well the ECG rollout is going I am going to visit the states for the next Watch and the one after that.

Apple adding more health features will make it even harder to get the features out in the rest of the world. If we get ECG for all Watches around the world before next year I might have fate in new features like blood pressure and glucos monitoring. But now it looks like it will be a rough long road for Apple to get it out there.

 

[69Mustang]

Please correct me if I'm wrong, but it was not that Apple got FDA approval as such, but the FDA had to create a new category in order to approve the Apple watch.
It would not have passed approval otherwise.

Incorrect. Apple got FDA Clearance, not Approval. They are different classifications. Clearance is not a new category. The app cleared as a Class II device. I linked a .pdf of their clearance letter further up thread.
https://www.fda.gov/medicaldevices/..._the_difference_between_Cleared_and_Approved_
Relevant excerpt:
What is the difference between Cleared and Approved?
In order for medical devices to be legally marketed (sold) in the United States, they are required to be cleared or approved by the FDA unless it is 510(k) exempt.

Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to (similar) another legally marketed device. A premarket notification submission is referred to as a 510(k) and must be submitted to FDA to review and provide clearance.

Approved medical devices: Approved medical devices are those devices that the FDA has approved a premarket approval (PMA) application or a Humanitarian Device Exemption (HDE) application. This review and approval process is for Class III medical devices (the ones with the highest risk) and involves a more rigorous review than the 510(k) review process.
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It's the price for posting on MacRumors. I’ve corrected my error, but I think the substance of my post still stands, which is it is a significant advancement that will have and has already had a positive impact on people's lives. And it is reliable enough that the FDA has cleared it. Had this been done by Samsung people would have been asking why Apple isn’t innovating the same way.

I disagree. Samsung got FDA Clearance for their S Health app back in 2014. https://www.mobihealthnews.com/28387/samsung-gets-fda-clearance-for-s-health-app
Nary a peep from anyone... including Samsung.

 

[itsmemuffins]

It’s a pity Apple is focusing all its health efforts only on America.

I know America is Apple’s single largest market… but there’s a hole world out side America’s borders.

It’s extremely short sighted of Apple. Also extremely disappointing to have bought a series 4 Apple Watch paying full price for it, only to have it hobbled.

Living in the EU I would have liked Apple to have gotten ecg clearance here too. In one fell swoop it would have been able to get clearance for 28 countries and a population almost double of America.

 

[Marcus PM]

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?

 

[MoreRumors?]

The problem is a lot of people are conflating FDA Clearance with FDA Approval. They are not the same. Apple has FDA Clearance. The media isn't helping because they aren't mentioning the distinction. They also aren't mentioning the restrictions on Apple's FDA Clearance. I'm betting most don't know that people under 22 years of age aren't supposed to use Apple's new features. I'd also bet that most don't know that the features aren't recommended for people who already have arrythmia's.

Apple has the opportunity to do some major good. They have to be transparent though because all that good can be ruined by lack of transparency. Just a hunch, but I bet that under 22 thing will throw a lot of people for a loop.
Apple's actual FDA Clearance letter. Prohibitions are on the first page.
https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180044.pdf

I agree with you and it is why I and everyone else should go directly to the FDA website to verify what has been reported.

 

[MikeMo]

Can't wait to see Samsung's approval process of their vaporware feature of blood pressure monitoring from a watch. Unless it is using a cuff that talks to the watch, this could be groundbreaking. I already use a cuff that sends to my iPhone (not sure why I would want it to send to the watch). Wrist monitors are not too accurate, so I doubt they simply added a cuff to the watch band. Can't wait to see it and how accurate it is.

I recall something about a patent indicating Apple was able to detect blood pressure by measuring the pressure wave timing - the time between when the beat occurs and the pulse arrives.

 

[Firelock]

Incorrect. Apple got FDA Clearance, not Approval. They are different classifications. Clearance is not a new category. The app cleared as a Class II device. I linked a .pdf of their clearance letter further up thread.
https://www.fda.gov/medicaldevices/..._the_difference_between_Cleared_and_Approved_.
[doublepost=1550947934][/doublepost]
I disagree. Samsung got FDA Clearance for their S Health app back in 2014. https://www.mobihealthnews.com/28387/samsung-gets-fda-clearance-for-s-health-app
Nary a peep from anyone... including Samsung.

My quote was referring specifically to an FDA-approved smart watch with ECG function. That is not at all what Samsung got cleared. Maybe no one, not even Samsung, spoke much about it because creating an app that compiles information is not really the challenge here as much as creating the miniaturized medical sensor hardware like Apple did?

 

[69Mustang]

My quote was referring specifically to an FDA-approved smart watch with ECG function. That is not at all what Samsung got cleared. Maybe no one, not even Samsung, spoke much about it because creating an app that compiles information is not really the challenge here as much as creating the miniaturized medical sensor hardware like Apple did?

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.