Apple Watch AFib History Feature Qualified by FDA to Evaluate Medical Devices

[MacRumors]

Apple's atrial fibrillation (AFib) history feature on Apple Watch has been qualified by the FDA under its Medical Device Development Tools (MDDT) program, the first digital health technology feature of its kind to do so.

Since 2022, Apple Watch has supported AFib History, which allows users diagnosed with atrial fibrillation to view an estimate of how frequently their heart is in this type of irregular rhythm.

The feature analyzes pulse rate data collected by a photoplethysmography (PPG) sensor to identify episodes consistent with AFib and provides the user with a retrospective estimate of AFib burden (a measure of the amount of time spent in AFib during past Apple Watch wear). Apple says the feature is intended for individuals aged 22 years or older who have been diagnosed with atrial fibrillation.

The AFib History feature received FDA clearance in the United States just prior to its announcement by Apple, after being validated in a clinical study. The MDDT program under which the feature was approved today is the FDA's method of qualifying tools that medical device sponsors can choose to use in the development and evaluation of medical devices.

According to the FDA, the Atrial Fibrillation History feature is:

• The first digital health technology qualified under the MDDT program, providing a non-invasive way to check estimates of atrial fibrillation (AFib) burden within clinical studies.
• Designed to be used as a biomarker test to help evaluate estimates of AFib burden as a secondary effectiveness endpoint within clinical studies intended to evaluate the safety and effectiveness of cardiac ablation devices to treat.
• Designed to be used throughout the clinical study, both before and after cardiac ablation devices, to monitor a study participant’s weekly estimate of AFib burden.

(Via MyHealthyApple.com.)

Article Link: Apple Watch AFib History Feature Qualified by FDA to Evaluate Medical Devices

 

[DelayedGratificationGene]

Hmmm quiet. Where is everyone with the snarky zingers? Cant with this one as Amazing Apple is once again saving lives!

 

[Godspeed8230]

That's really great.

 

[james yates]

Never heard of atrial fibrillation until my watch told me I had it.,Thank you Apple, still here and going well.

 

[DelayedGratificationGene]

Never heard of atrial fibrillation until my watch told me I had it.,Thank you Apple, still here and going well.

Awesome! All the best james

 

[neuropsychguy]

This is hugely important to those who have atrial fibrillation or don't know they have it. This clearance will save lives (e.g., https://doi.org/10.1161/JAHA.120.020163) and improve people's quality of life. AFib is treatable and manageable (e.g., https://doi.org/10.1161/JAHA.121.022555). If it isn't treated or managed, it can do all sorts of adverse things to your body (including increased mortality) and brain (something I've researched).

 

[kiranmk2]

The problem Apple is and will run up against is that the FDA move so slowly to approve things. I guess this was understandable in the past when people had to be recruited for studies and low numbers of people meant there either needed to be multiple studies or long duration studies, but given how prevalent the Apple Watch is, it sounds like study groups can be much larger and the studies get a lot of 24/7 data (whilst the watch is warn). I really hope that using these type wearables can lead to more rapid studies and approvals moving forwards.

 

[Red_Bran_Porridge]

I’m not exactly sure this is a good thing. I’m sure this is great for Apple since they’re trying to push the Apple Watch as a health device, and they’re generally trying to go after the health market. But is that all it is?

 

[tomtad]

Anyone remember the Pixel Watch?

 

[star-affinity]

Great! Love health tech like this. Nice one, Apple.

Personally I'm eager for Susan Shore's device for tinnitus to go through FDA approval, hopefully it does and as soon as possible. 😣

Now if the Apple Watch could fix tinnitus, that would be something.
It can actually prevent it in a way by measuring sound volume and warning if it's too loud.

 

[Apple_Robert]

This is awesome news. Many more lives will be saved because of this feature.

 

[murdoc2k]

The health and watch team is crushimg it 💪🏼 This gives me hope that Apple is still the company that pushes boundaries for the greater good of humanity.

 

[burgman]

I’m not exactly sure this is a good thing. I’m sure this is great for Apple since they’re trying to push the Apple Watch as a health device, and they’re generally trying to go after the health market. But is that all it is?

What does this even mean? Is it a space laser thing?

 

[michaelsviews]

How many cardiologists actually take into account what the watch is reporting?
Dr = Yes your watch says AFIB, but our ECG says there are no signs of AFIB and you have no family history.

Now where's the diabetes & stress functionality that apple said it was going to have way back when?
For what you pay for the device it should have everything included so that you don't have to buy 3rd party apps.

 

[polyphenol]

There are some of us for whom that might have appeared relevant, interesting and helpful. But in reality it is not.

Not once you know that is how you are. I actually got my Apple Watch because I knew I had afib and hoped to identify when it occurred and if anything prompted it - or helped to resolve it.

This really isn't a complaint at all. If it is speaking the truth, it is hardly an issue for Apple!

 

[montuori]

How many cardiologists actually take into account what the watch is reporting?

Indirectly? Every one who sees a patient who made an appointment because their watch alerted them to the possibility of a problem. False positives happen in medical testing, presumably the watch is within approved guidelines for this.

 

[Red_Bran_Porridge]

What does this even mean? Is it a space laser thing?

Maybe I should have clarified. How good could an Apple Watch health feature be if the standards are so low? It’s a bit similar to the rumoured future AirPods having hearing health features, and how recent US regulations no longer require prescriptions for hearing aid devices. How good can a health product be if the standards are so low?

 

[KanosWRX]

This is amazing and one of the #1 reasons the Apple Watch continues to be the only watch I would ever get at this point. Their focus on health is very important to me, and I don't mean exercise.. but overall health. Glad they continue to innovate in this space! Honestly their phones are less impressive and differentiated these days to me then their watches and that's what keeps me in their ecosystem.

 

[Alameda]

I have a friend who told me his Apple Watch detected a heart problem. He went into his doctor and they had him in open heart surgery a few days later. Saved his life.

 

[spartan1967]

Hmmm quiet. Where is everyone with the snarky zingers? Cant with this one as Amazing Apple is once again saving lives!

Why does enabling AFib history turn off irregular rhythm notifications? And why do you have to be diagnosed with atrial fibrillation by a doctor to enable this feature?

It's just been qualified by the FDA. This is completely counterintuitive.

 

[ElvisThePelvis]

I have a few AFIB attacks per year. The Emergency Room near my house takes my watch results quite seriously and it has been 100% in catching me in AFIB, validated at the hospital each time of course. I've gotten pretty good at recovery as well, my last AFIB attack was in October. I woke up in AFIB, alerted by my watch. From the first alert at 7 a.m. until treatment and Cardioversion at 11 a.m. my watch was consistently reporting with the medical equipment. That was the fastest attack to treatment I had experienced.

I appreciate the health features in the watch more than most I think.

 

[Bobbuilds69]

I’m not exactly sure this is a good thing. I’m sure this is great for Apple since they’re trying to push the Apple Watch as a health device, and they’re generally trying to go after the health market. But is that all it is?

What else do you want it to be?

 

[StanleyOmar]

I’m not exactly sure this is a good thing. I’m sure this is great for Apple since they’re trying to push the Apple Watch as a health device, and they’re generally trying to go after the health market. But is that all it is?

Curious why that wouldn't be enough. They've managed to turn what was essentially just a watch that, in some ways, could do what the phone in your pocket already could, into an incredibly useful health monitoring device for so many people who would otherwise have no really need to buy this particular watch. I took forever to get an Apple Watch (received it as a gift, actually), and I still only really use it at work and for exercise, but now admit that it's perfect in those two situations.

 

[The Apple Bitch]

Anyone remember the Pixel Watch?

*Proceeds to cry in windows phone*

 

[StanleyOmar]

.