Ann: GMV Granted FDA 510(K) Clearance - Prizma Smartphone Jacket, page-421

As an Apple watch user, I can assure you the heart rate monitor is one of the most used features. Many users are buying the Apple watch for the fitness element and metrics behind it.

The device is not yet capable of being used for official diagnoses but it is a useful tool for monitoring during exercise etc. Apple also announced this morning 'Heart Study' to further their medical research.

But if the data being collected is not official or certified by the FDA then Apple are just conducting a research project with some utility of potentially notifying a user before a serious condition arises.

For chronic conditions, an Apple heart rate monitor doesn't cut the standard and this is GMV's opportunity.