Apple Gains FDA Clearance for ECG App for Apple Watch Series 4

Apple Watch Series 4 will feature two new medical apps marketed with FDA’s blessing, thanks to De Novo classifications. The new watch will offer an ECG app, a software-only mobile medical application that can classify whether there are signs of atrial fibrillation (AFib), and another software-only mobile medical app analyzing pulse rates for irregular rhythms. (Neither is intended to replace "traditional methods of diagnosis or treatment," FDA stated in the notices.) These features are scheduled to be available in the United States later this year, Apple COO Jeff Williams said during the company’s September 12 launch event. And, with a next-generation accelerometer and gyroscope, Series 4 can now detect falls to alert consumers and summon emergency services if needed. These features (along with enhanced design, aesthetics, and other consumer conveniences) can allow consumers to create what Williams called “the ultimate health and fitness watch.”  Apple Watch has offered an “optical heart sensor” from its beginnings, he said, but “we wanted to do even more in this space, so we are launching three new heart features.” Powered by that optical heart sensor, Apple Watch Series 4 will be able to detect and notify users of a low heart rate and of an irregular...
Source: MDDI - Category: Medical Devices Authors: Tags: Digital Health Source Type: news