Apple FDA regulated

Heart Study app could be Apple's first FDA-cleared product

By Jonah Comstock 03:23 pm February 1, 2018

The Apple Heart Study — which began enrollment at the end of November — has now begun data collection, with participants receiving prompts over the weekend to sign informed consent documents and initiate data collection. That document also reveals some new details about how Apple plans to use data collected during the study. “This study is part of the development of a new investigational device...

FDA's Apple memo points to company's aim to stay unregulated by the agency

By Brian Dolan 11:41 am June 10, 2014

When we first learned that a small team of Apple executives met with FDA officials last December to discuss mobile medical applications, it seemed likely that the discussion was intended to help Apple better avoid FDA regulation for its rumored health products. Thanks to a successful Freedom of Information Act request from the Apple-focused resources site Apple Toolkit, the FDA has furnished a...