Calgary Scientific has received FDA clearance to market ResolutionMD Mobile as a mobile diagnostic application in the U.S. The server-based software allows physicians to access, view and interact with patient images and reports stored within any healthcare facility, and render a clinical diagnosis using their mobile devices.
ResolutionMD supports multiple mobile devices and operating systems. The initial FDA clearance applies to versions running on Apple iPhone and iPad devices. The mobile app performs on 3/4G wireless, and ensures that no highly sensitive or confidential patient information is retained on the mobile device.
ResolutionMD Mobile incorporates capabilities including: interactive 2D, MIP/MPR and 3D advanced visualization; anywhere, anytime access to and interactive use of MR and CT images; HIPAA compliance; concurrent support for Apple iPhone and iPad, as well as Android devices and ambient light user assessment.
Future versions of the server-based software will support an expanded list of mobile devices and operating systems, and supplementary applications to the FDA for clinical diagnostic imaging approval on those devices other than the iPhone and iPad will occur, the Calgary, Canada-based provider of advanced visualization software said.
Prior non-diagnostic versions of this product are currently distributed and licensed under original equipment manufacturer agreements.
In addition to the recent FDA clearance, ResolutionMD Mobile has also been licensed by Health Canada and bears the CE mark for distribution in Europe, according to Calgary Scientific.