- March 15, 2022
The FDA letter, dated October 22, stated that, after reviewing Apple’s 510(k) premarket notification of intent to market the device, the FDA determined that the device is substantially equivalent to legally marketed predicate devices for the indications Apple sought.
Apple designed its “Irregular Rhythm Notification Feature 2.0” (IRNF 2.0) to include two mobile medical apps — one on Apple Watch and one on the iPhone. The apps analyze pulse rate data collected by the watch’s PPG sensor to identify episodes of irregular heart rhythms consistent with AFib. They can provide a notification to the user.
The background screening tool uses the PPG sensor on the Apple Watch Series 3, Series 4, Series 5 and SE. There is no way for a user to initiate analysis of pulse rate data. If the irregular rhythm consistent with AFib is identified and confirmed, IRNF 2.0 Watch app will notify the user and transfer the AFib notification to the iPhone Health App through Apple’s HealthKit sync. It will encourage the user to seek medical care. The app will display a history of all prior AFib notifications and allow the user to view a list of times for the irregular rhythms contributing to the notification.
Apple’s irregular rhythm feature is a software-only mobile medical application indicated for use with the Apple Watch and intended for over-the-counter use. FDA said it is not intended to provide a notification on every episode of irregular rhythm suggested of AFib, and the absence of a notification is not intended to indicate that no disease process is present.
Data captured through the feature are only captured when the user is still and the feature is not intended to replace traditional methods of diagnosis or treatment. It has not been tested for and is not intended for use in people under 22 years old or for individuals previously diagnosed with AFib.
FDA clearance is a huge step forward in Apple’s foray into health diagnostics, with several collaborations and other efforts concurrently in the works.
Within the past 14 months or so, the tech giant has partnered with Anthem on a study using smart devices to manage asthma, entered into a virtual research study in collaboration with Biogen for monitoring and screening cognitive health and was mentioned by Rockley Photonics as a potential partner for introducing new blood sugar and blood pressure monitoring functions to the Apple Watch.
REFERENCE: Mass Device; 08 NOV 2021; Sean Whooley