FDA Approves Mobile MIM Radiology Application for Portable Devices

On Friday, the FDA approved Mobile MIM, an application that allows physicians to view radiology images using an iPhone or an iPad. Mobile MIM can display computed tomography scans, MRIs, and images created with positron emission tomography with sufficient quality in most cases to make diagnostic decisions. The FDA cautions that although Mobile MIM facilitates diagnoses when physicians are away from the office, it "is not intended to replace full workstations and is indicated for use only when there is no access to a workstation."

 

In a press release, William Maisel, MD, MPH, chief scientist and deputy director for science in the FDA's Center for Devices and Radiological Health, said, "This important mobile technology provides physicians with the ability to immediately view images and make diagnoses without having to be back at the workstation or wait for film."

 

Once the radiology images are captured, the Mobile MIM program compresses the files and transmits them to the designated mobile device, which must have the Mobile MIM application installed to view the files. The program lets the physician measure distance and intensity values on the images and to display measurement lines, annotations, and regions of interest.

 

Working with experts in radiology, the FDA investigated whether the program would display images with the same quality regardless of the portable device used and in a variety of lighting conditions. Although tests recorded variation in luminance levels between devices—even when the make and model were identical—the FDA reported that "all participants agreed that the device was sufficient for diagnostic image interpretation under the recommended lighting conditions."

 

Mobile MIM comes with documentation on optimizing image viewing and includes a built-in contrast test that allows the physician to assess whether current lighting conditions provide an adequate picture for making a diagnosis. Despite these safety precautions, the FDA declined to approve Mobile MIM for viewing mammography images or X-rays.

 

Mobile MIM was developed by MIM Software, Inc., in Cleveland, Ohio. The company's Website notes that the application is available in 14 languages and is already used in dozens of countries throughout Europe, Asia, and Latin America. It won the Apple Design Award for Best iPhone Healthcare & Fitness Application 2008, and Robin Rhys from AppAdvice.com recorded a demonstration of Mobile MIM at MacWorld in 2009, which you can view below.

 

 

 

Mobile MIM is the first radiology application approved by the FDA. MIM software said it expects to make the application available for purchase through the US Apple App Store next week. With more than 90% of US physicians using smartphones and preferring the Apple iPhone over Blackberry at a 2:1 ratio, according to a 2010 survey by Spyglass Consulting Group, the potential market for the application is sizable. When iStethoscope debuted for the iPhone in 2010, for example, it was downloaded by more than 3 million physicians worldwide, according to its creator Peter Bentley, a researcher at University College London.