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Topic: FDA

Apple Watch Series 4 EKG tech got FDA clearance less than 24 hours before reveal

09/18/2018, 10:09 am

The electrocardiogram feature in the Apple Watch Series 4 got clearance from the U.S. Food and Drug Administration just a day prior to Apple's Sept. 12 press event, reportedly causing some stress at the company.

19 comments

Apple joins FDA pilot program allowing it to skip some rules for health products

09/26/2017, 01:09 pm

Apple has been picked as one of nine companies for a pilot program by the U.S. Food and Drug Administration, which which will let the firms avoid regulations that can slow the development of health-related products.

14 comments

Recent Apple emails with FDA reveal interest with cardiac monitoring hardware, Parkinson's support

11/29/2016, 10:11 am

A recent Freedom of Information Act filing has revealed that Apple's ambitions still extend into cardiac monitoring technologies, with meetings scheduled between the Apple Watch maker and the U.S. Food and Drug Administration over the summer of 2016 regarding a pair of devices.

1 comments