Apple Gets 510(k) Clearance for Irregular Rhythm Notification Feature 2.0 App

Tech giant Apple has received the FDA’s 510(k) clearance for its Irregular Rhythm Notification Feature (IRNF) 2.0 app.

Apple had announced back in December 2018 that an irregular heart rhythm notification was available on its Apple Watch. “Using the optical heart sensor in Apple Watch Series 1 or later, the irregular rhythm notification feature will occasionally check the user’s heart rhythm in the background for signs of an irregular heart rhythm that appears to be AFib and alerts the user with a notification if an irregular rhythm is detected on five rhythm checks over a minimum of 65 minutes,” the Cupertino, Calif.-based company said.

The FDA classifies IRNF 2.0 as “photoplethysmograph analysis software for over-the-counter use,” a Class II (Special Controls) device.