“Apple announced that the US Food and Drug Administration cleared two new features for the Apple Watch Series 4. One is an advanced method of monitoring the heart called an electrocardiogram (EKG), and the other is the Watch’s ability to detect and notify the user of an irregular heart rhythm,” Angela Chen reports for The Verge. “Both features will be available on the device later in 2018 (not at launch).”
“The FDA clearance letters for both the EKG and irregular rhythm notification functions note that they are not intended to be used by people under the age of 22,” Chen reports. “Second, it’s important to understand that the FDA has ‘cleared’ both apps, but that’s not the same as ‘approving’ them.”
“The most advanced is FDA approval, which is done only for Class III products, or technologies that might have higher risk but also a higher benefit. (Think: implantable pacemakers.) Approval is the gold standard, and companies need to do a lot of testing to receive this designation,” Chen reports. “The Apple Watch is in Class II. For Class II and Class I, the FDA doesn’t give ‘approval,’ it just gives clearance. Class I and Class II products are lower-risk products — as Speer puts it, a classic Class I example is something like a tongue depressor — and it’s much easier to get clearance than approval.”
“Apple, however, has emphasized that it has received a ‘de novo’ classification for the EKG feature,” Chen reports. “That means that… 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.)”
Read more in the full article here.
MacDailyNews Take: AliveCor? DeadCor is more like it.
SEE ALSO:
AliveCor CEO Gundotra says that Apple is using ‘alternative facts’ to market Apple Watch Series 4 – September 13, 2018
Apple Watch Series 4 redesigned with a stunning new display, breakthrough electrocardiogram, and much more – September 12, 2018