SoylentNews Comments | FDA Approves First Medical Device Accessory for the Apple Watch

FDA Approves First Medical Device Accessory for the Apple Watch

posted by Fnord666 on Friday December 01 2017, @10:28AM

from the in-a-heartbeat dept.

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

Original Submission