FDA Qualifies Apple Watch's AFib History For Use In Clinical Studies

In a first for "digital health technology," the Apple Watch's atrial fibrillation (AFib) history feature has been approved by the FDA to join the FDA's Medical Device Development Tools (MDDT) program. This means the wearable is now usable in clinical studies. The Verge reports: The FDA announcement describes using it as a noninvasive way to collect the data both before and after treatment: "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."

Balance

[CaptQuark]

This is a win after having to disable the blood oxygen sensor due to the patent dispute with Masimo. I guess it balances out.

https://apple.slashdot.org/sto... [slashdot.org]

Re:Balance

[Camembert]

well, it sure looks like you could use a blood pressure sensor on your wrist, medical grade or consumer grade...

Re:

[ElizabethGreene]

I read this differently. I read it as "Instead of having to wear a Holter monitor during a clinical trial, you can use your apple watch instead."

Bias disclosure, my Fitbit warned me of a high heart rate in December, was subsequently diagnosed with Atrial Flutter and Fibrillation, cardioverted twice, and underwent a cardiac ablation ~2 weeks ago. This topic is of interest to me.

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[fullgandoo]

Buy some Apple shares, also MS, Google, Facebook and Meta! It will calm you the fuck down!

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[omnichad]

The approval is just as secondary continuous monitoring that is paired with occasional in-person monitoring. The sensor really only has to be in the right ballpark to be useful in this case.

Ditto Samsung

[davecb]

https://news.samsung.com/us/fd... [samsung.com]

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[RUs1729]

apple is always right behind Samsung with innovations

When it comes to hardware. When it comes to software Samsung is behind everybody else.

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[ACForever]

Sure, you trust your life to a fashion company instead of a company that makes medical grade equipment. We will let Darwin take care of you apple cultists.

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[UnknowingFool]

That is rather false dichotomy thinking. Did you even read the link where it says specifically the feature was approved for "over-the-counter" use. As such, the FDA and doctors are not going to suggest the watch be the ONLY diagnostic tool to use in a situation. If the watch notifies someone of a problem, that person should seek medical attention. Did you think that an alert by an Apple Watch means the person is immediately put on a heart transplant list? Did you think that hospitals have replaced all their

AFib watch?

[RUs1729]

Am I the only one who thinks that's an unfortunate name selection?

Re:

[UnknowingFool]

AFib [wikipedia.org] is a medical abbreviation for atrial fibrillation. Apple did not choose the name in medicine. I suppose Apple could have given it a new name like iBeat but seeing how the context is medical, using a new name is probably not a good idea.

CGM

[arnott]

When Apple or Samsung get FDA approval for Continuous Glucose Monitor (CGM) for their watches, that will be a game changer for people's health.