MIM Software Inc.’s diagnostic medical imaging app for the Apple Inc. (NSDQ:AAPL) iOS platform is now available for download.
The Food & Drug Administration-cleared diagnostic is the first-ever mobile radiology app to receive the agency’s seal of approval.
"Mobile MIM" is designed for remote viewing of CT, PET, MRI, and SPECT images on the iPhone, iPod touch and iPad. The software won 510(k) clearance from the FDA earlier this month, a process that took nearly three years to get through the agency. Software applications that Apple accepts for sale or free download in the iTunes App Store are subject to an approval process.
The application is only available on the Apple iOS mobile platform because of its "combination of massive market penetration and a lineup of devices that are both tightly controlled in their manufacture and consistent in their characteristics," said MIM Software CTO Mark Cain in prepared remarks.
Mobile MIM is intended only for healthcare professionals, but the Cleveland, Ohio-based company plans to release "VueMe," a similar app intended to patient use in March. VueMe falls into the FDA’s Class I category of medical devices and software, which means it will need to adhere to the FDA’s quality standards, but won’t need to undergo a 510(k) review like its big brother.