nidan7500 Wednesday, 04/03/19 12:51:46 PM Re: None Post # of 236919 New position paper from FDA on AI. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635083.htm We want to keep in mind that the recent AVXL Consortium discussion and PR by FDA brings ERP and AI into play w/Pharma. This set of circumstances will mean both Pharma and medical device regulatory requirements apply. These are know as Combination Products, which can get complicated in licensing. Not to worry, Merck/Sage/Cognision/AVXL etal, will figure it out w/strong support all around. Also note the recent patent app (AVXL/Cognision) suggests the Pharma S/W-H/W is for an outpatient service. I think that last part is going to be a factor as patent rights to a service do get to generate enormous royalties for a long time (see semiconductor physics planar process royalties as an example). As the AI FDA announcement indicates. The future uses for this technology bode for Precision Medicine. Once established, these new tools will allow fuller application of high speed, accurate benefits to CNS disease uses.