“How many mobile medical apps have received 510(k) clearance from the FDA? It’s a question I get asked often. For a while the standard response that I’ve given and heard others give was that you could count on two hands how many apps have received FDA clearance. Over the course of the past two years, however, it has become clear that an increasing number of wireless-enabled medical devices with companion apps were securing FDA clearances. Based on a review of the MobiHealthNews archives, but more importantly, the FDA’s database of summary decisions for 510(k) clearances, we have found more than 75 510(k) clearances that included a mention or description of a mobile software component — and compiled our findings into our latest MobiHealthNews Research report: 75 FDA Regulated Mobile Medical Apps.”
Article
Brian Dolan, mobihealthnews, 20 December 2012
