The latest Apple Watch Series 4 includes a new electrocardiogram (ECG) app, allowing users to take an ECG reading right from their wrist, as well as an irregular rhythm notification feature. Both features were granted De Novo classification by the Food and Drug Administration (FDA) and will be available later this year.
The ECG app creates, records, stores, transfers, and displays a single channel ECG similar to a Lead I ECG and can determine the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The ECG recordings are then stored in the Health app and can be shared with physicians. The ECG app is not recommended for users with other known arrhythmias or for individuals <22 years old.
The irregular rhythm notification feature analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification to the user. The feature is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis; data are only captured when the user is still. The irregular rhythm notification feature can be used to supplement the decision for AFib screening but it is not intended to replace traditional methods of diagnosis or treatment. It is also not intended for use in those <22 years old or in patients previously diagnosed with AFib.
Another new feature is the accelerometer and gyroscope which are able to detect hard falls. The watch sends the user an alert after a hard fall which can either be dismissed or used to contact emergency services. If the watch senses immobility for 60 seconds, it will automatically call emergency services and send a message along with location to emergency contacts.
“The FDA worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly,” said FDA commissioner Scott Gottlieb, MD in a press statement. “Healthcare products on ubiquitous devices, like smartwatches, may help users seek treatment earlier and will truly empower them with more information about their health.”
For more information visit Apple.com.