It’s a watch, it’s a phone, it’s a medical device?
At the annual September convention, Apple launched the Apple Watch Series 4 that comes packed with health features. It will warn when a wearer has fallen down, it will monitor your heart rhythm and it will enable customers to take an ECG or electrocardiography reading, right from their wrist.
With the app, users touch the Digital Crown and after 30 seconds, receive a heart rhythm classification. It can classify if the heart is beating in a normal pattern or whether there are signs of Atrial Fibrillation (AFib), a heart condition that could lead to major health complications.
At the launch, Apple claimed the app came with Food and Drug Administration’s ‘approval’. Since then, they’ve clarified that they have FDA’s ‘clearance’. FDA is US federal public health regulator.
But coming back to the original question, is it a legit medical device?