There are ongoing significant changes for monitoring devices. Apple is working closely with the FDA according to some email conversation Digital Health Space has obtained.
In addition to this information the International Medical Devices Forum has held meetings regarding devices, to which Apple has attended. In the United States the FDA is represented by
The contestants thus far are:
InPen and mobile app
FreeStyle Libre Pro
Lumify ultrasound system, Cardiac U/S
Clarius Mobile Health
These devices and many others are in the FDA pipeline. Many companies such as software companies are unfamiliar with the FDA device approval process. Many are in 'sleuth mode' to avoid tipping off their competitors in the health market.
The consumer market is still hazy and most consumers do not know how to acquire information or where to purchase the devices.
Options available are: Amazon, BestBuy, CVS, RiteAid and by prescription via an online pharmacy.
The devices may be acquired through a health plan buyer's group or Pharmacy Benefits Manager.
The investor risk is substantial, and companies are hedging their bets by entering the market gingerly
Thirty-six connected health apps and devices the FDA cleared in 2016 | MobiHealthNews