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The U.S. Food and Drug Administration (FDA) has approved an EKG reader medical device accessory for the Apple Watch:
Up until now, AliveCor has used the KardiaMobile device, which was stuck to the back of your smartphone and paired with an app to detect abnormal heart rhythm and atrial fibrillation (AFib). The new Apple Watch accessory, Kardiaband, clicks into a slot on the Watch band to do the same thing.
However, rather than needing to hold your smartphone with both hands for 30 seconds to get a reading, you can get an EKG reading continuously and discreetly just by touching the band's integrated sensor.
[...] EKGs are usually only available in offices and hospitals — and only after a life-threatening event. Having one on your wrist that you can use to check your heart and then send a readout straight to your doctor is vital to prevention of a heart attack or stroke. And, as Gundotra also points out, "It's not possible to diagnose atrial fibrillation without FDA clearance. That is a big, big play."
It's worth noting Apple could easily replicate what AliveCor is doing. It has all the right equipment within the Apple Watch and the manpower to do so. However, it doesn't seem likely Apple would want to go through the hassle of FDA approval for the Watch, which is a general purpose device used for numerous other applications besides getting your heart rate.
Also at CNET and Fast Company.
Update: Apple launched a study to look for irregular heart rhythms on the Apple Watch (just as feared)
Previously: Apple Watch Could be Used to Detect Hypertension and Sleep Apnea
(Score: 3, Informative) by All Your Lawn Are Belong To Us on Friday December 01 2017, @03:57PM
Except that this is something less than even a four lead ECG monitor. It's a two point of contact monitor (single lead), which has incredibly limited utility for diagnosing anything. It may help indicate to a doctor you have AFib, and it would show other gross anomalies that you'd be calling an ambulance for already due to symptoms. And guess what your doctor will do even if it provides a textbook-perfect recording? Order a twelve-lead ECG and maybe a stress test, or a Holter monitor.
You can also be experiencing AFib and be completely asymptomatic, which is why you need a constant monitor, not a "I'll check it when I feel bad" thing.
It also seems to be (and I could be wrong on this one) a touch-the-fingers-to-it-and-it-will-record. It almost has to be that way since you need bilateralism to get anything and the watch sits on one wrist. What that means: It's not like a Holter monitor, which is continuously monitoring your heart. (By the way, things like Holter monitors rule out the claim above that you need to be in a doctor's office.)
Also, looking at AliveCor's website and their clinical documentation... they have two presentations and a published letter to the editor of a journal. No peer reviewed studies.
It's not a toy - FDA certification means the software is safe for the medical application applied for. But I'm wondering what precisely it's been certified to the FDA for. It's a big process but devices are usually cleared for certain procedures. So it will be interesting if clinicians (in general) actually make anything out of it, or simply keep to the established standards. In the meantime, you could get one and play doctor with yourself! :)
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