Apple Inc. are now developing Medical Devices...

Apple Series 4 Watch is now a Medical Device. (September 2018)

“The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your De Novo request for classification of the ECG App, an over-the-counter device under 21 CFR Part 801 Subpart C, with the following indications for use: The ECG app is a software-only mobile medical application intended for use with the Apple Watch to create, record, store, transfer, and display a single channel electrocardiogram (ECG) similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. …”

FDA statement >>>
 

For information on the “FDA approach to Medical Device Classification” >>>