Saintel Daily

Apple, Google and Fitbit Receive Fastpass from FDA for Health Apps

The U.S. Food and Drug Administration has named the companies involved in a recently instituted “pre-certification” program that determines whether or not they meet baseline quality standards for health software. Apple, Fitbit and Samsung and Alphabet’s Verily are among the firms that will help the FDA set the benchmarks and decide just how much information…
23andMe Will Start Testing for Genetic Conditions After Approval from the FDA

Over the last few years I’ve seen commercials for the service 23andMe. Framed as a way to trace your ancestry in an attempt to know more about yourself. Which really interests me, as I am a self proclaimed genealogy nerd. Well, other people probably think it’s nerdy also. What’s interesting about 23andMe is that…
The FDA wants to Regulate Wearables

You can add this to the its about time file.The FDA will regulate wearables making health claims. It seems that everyone is putting on a smartwatch to be healthier. However these device are not serious medical devices. The distinction is very important and should be regulated by the FDA. Seems the FDA agrees with this line of thought as…

Apple, Google and Fitbit Receive Fastpass from FDA for Health Apps