FDA approves Galaxy Watch heart monitoring app

US regulators have approved for sale a Samsung app that monitors for early signs of heart attacks via its Galaxy Watch wearable.

The US Food and Drug Administration (FDA) approved the Irregular Heart Rhythm Notification (IHRN) feature of the Samsung Health Monitor app, the electronics giant said.

Alongside the app’s existing on-demand electrocardiogram (ECG) function, the IHRN feature “proactively monitors heart rhythms suggestive of atrial fibrillation (AFib), right from their wrist,” Samsung said.

AFib — a type of arrhythmia — is widely considered a warning sign for cardiovascular complications that can increase the risk of strokes and heart failure.

Once activated in the Samsung Health Monitor app, the IHRN feature checks for irregular heart rhythms in the background via Galaxy Watch’s BioActive Sensor.

Once the number of consecutive irregular heart beats goes over a certain threshold, the app sends a notification to the user through Galaxy Watch  warning of potential AFib activity, and prompting them to take an ECG using their watch for a more accurate measurement.

IHRN feature would fall under the FDA category of software as a medical device (SaMD). In recent years there has been a sharp growth in the popularity of this category of health-monitoring tech.

In recent interview with CET&D, this expansion was confirmed by Brendan O'Leary, the deputy director of the FDA digital health center of excellence, which is responsible for regulating medical- and wellness-related electronics.

O'Leary told the magazine: “There’s growth both in wearables and in software as a medical device (SaMD). There's growth in augmented and virtual reality-enabled medical devices and artificial intelligence (AI) and machine learning-enabled medical devices. There's a lot of exciting technologies hitting the med tech sector right now.”