FDA health app regulation

By Jonah Comstock 11:45 am April 8, 2013
The FDA has granted Class II prescription-only 510(K) clearance for an iPhone-enabled vision test. The software, called myVisionTrack, was developed by Vital Art and Science. The FDA clearance applies to the software when run on an iPhone 4S. Vital Art and Science has developed the test for patients with serious degenerative eye conditions such as diabetic retinopathy (DR) and age-related macular...
By Brian Dolan 04:14 am April 21, 2011
In recent months it's become clear that the media is increasingly turning its attention to mobile health. The attention, of course, is welcomed by most everyone working in mHealth today, but sometimes it's painful to read the hyperbole, exaggerations, and misconceptions that are perhaps inevitable with the increase in coverage. Proteus Biomedical is one company that has noticed this hyperbole....