Mobile MIM is first radiology application to earn FDA clearance

Optimism was the key word surrounding last Friday's approval by the Food and Drug Administration of Cleveland-based MIM Software's Mobile MIM application, which will allow doctors using iPhones and iPads to view CT, MRI and PET images on their Apple devices.

Mobile MIM initially was the first medical app to grace Apple's AppStore in 2008, reports Diagnostic Imaging. Regulatory concerns forced Apple to remove Mobile MIM from its store a short time later. After two failed 501(k) applications, the company received a 510(k) clearance today. 

Any CT, MRI or PET images taken by a hospital or at a provider's office are sent to the appropriate portable device after being compressed for a secure network transfer through the Mobile MIM software, according to the FDA's press release. The software allows providers to measure both distance and intensity values for the images. 

MIM Software chief technology officer Mark Cain sees the approval as a harbinger of things to come in the mobile health space. "I think the veil is being lifted on the FDA's approach to mobile devices and mobile applications and mobile health in general," Cain told Diagnostic Imaging

Cain added via MIM Software's website: "Establishing a diagnostic protocol for medical imaging is no simple matter for a device like the iPhone or the iPad. It is critical to understand the characteristics of the device and to establish methods and tools that are safe and effective, while working within those constraints. There has been a gap in the market for a remote imaging device like this, and now it can be filled." 

William Maisel, MD, the deputy director for science in the FDA's Center for Devices and Radiological Health, called the app "important technology" that gives doctors the freedom to make diagnoses "without having to be back at the workstation or wait for film." 

The app, which won the 2008 Apple Design Award for Best iPhone Healthcare & Fitness Application, should be available in the U.S. Apple App Store this week. It currently is available in 34 different countries and 14 different languages outside the U.S. 

For more information:
- view the FDA announcement
- read this Diagnostic Imaging article (registration required)
- check out MIM Software's website

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