“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.
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