Monday, January 2, 2017

Thirty-six connected health apps and devices the FDA cleared in 2016 |

Over the past year, 36 devices have received clearance from the Food and Drug Administration. 

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.

Scoop: Emails show FDA asked Apple to advise on Software as a Medical Device

Scoop: Apple emails show plans for two FDA-regulated cardiac devices

As the world’s medical device regulators work to harmonize how best to regulate software as a medical device (SaMD), MobiHealthNews  learned via a Freedom of Information Act request that the FDA invited Apple to join an international task force focused on shaping this future regulatory framework. Apple executives quietly joined a working group within the International Medical Device Regulators Forum (IMDRF), a group of regulators, scientists, legal experts and physicians from the US, Canada, the European Union, Australia, China, Russia, and Brazil to pursue harmonization of the regulatory approach to standalone medical software.

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  
  • Bakul Patel
    US Food and Drug Administration
  • Dr. Doug Silverstein
    US Food and Drug Administration
The contestants thus far are:

Sensimed   Triggerfish     
Trak system (male fertility measurements)       


Temp Sitter.     
InPen and mobile app      
FreeStyle Libre Pro     
AirStrip ONE

Ellipta inhaler.     
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

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