Our third installment of the mobile medical apps series finally features a mobile medical app. This app in particular, the MediCal QAWeb Mobile app, is used to calibrate the screen of an iPad for diagnosis of medical images viewed on said iPad (both versions 1 and 2 according to the article).
The most intriguing part about this application, made by Barco, is that it is not a medical device. Furthermore, Barco has worked with the FDA to consider the software a "master file" (defined by wordnetweb.princeton.edu as a computer file that is used as the authority in a given job and that is relatively permanent). In this manner, the FDA is allowing developers of image viewing software to include this app in their 510(k) submissions. In Barco's press release, they state: "This will help reduce the regulatory effort for FDA clearance, leaving more time and resources for product development." That's always the goal for companies - identify the least risky, most predictable regulatory pathway, and it seems that Barco's MediCal QAWeb Mobile app will go a long way to help software developers ease the pain of a 510(k) submission.
-RTK
Image Credit: Eivind Barstad Waaler on Flikr