USA – Apple Sets the Stage for FDA Regulation on Two Types of AFib Mobile Medical Apps

The US Food and Drug Administration (FDA) granted two de novo classification requests on Tuesday on applications to be used with the Apple Watch for identifying irregular heart rhythms.

Both devices are software-only mobile medical applications for over-the-counter use designed to aid in the process of determining risk of atrial fibrillation (AFib), though they are designed to help Apple Watch users supplement traditional methods of diagnosis or treatment, rather than replace such methods.

One is intended for the display of electrocardiograph data, whereas the other is designed to notify users of AFib-suggestive episodes based on users’ pulse rate data. Neither are intended for use by patients under the age of 22, according to the letters FDA issued to the tech giant…