In February 2011, MIM Software’s Mobile MIM app became the first mobile application cleared by the FDA for viewing and making diagnoses based on CT, MRI, and PET scans. However the road to gaining that historic approval wasn’t always easy. Getting approval 
In June 2008, MIM Software’s CTO, Mark Cain, presented the Mobile MIM application at Apple’s World Wide Developer Conference. Soon after the conference, Apple launched the App Store and Mobile MIM was available for download but not for long. It was then quickly yanked from the App Store because the FDA had not approved the application. “Within only a few weeks of submitting, we were contacted by the FDA and told that our app could not be on the app store (despite the fact that it was both free and labeled as “not intended for diagnostic use”) because it served as marketing for a device that was not cleared for marketing. We promptly removed it,” Cain said in an interview with mobihealthnews.com. One year later, MIM resubmitted a 501(k) to the FDA with data from clinical trials. That submission was also denied. Finally, the FDA granted clearance on the third submission, two and a half years after it originally launched with the App Store. Today, it is one of the best healthcare applications on the market. Using the app The MIM Mobile application essentially mobilizes the MIM’s workstation software so doctors can review CT, MRI, and X-ray images in high resolution and make diagnoses right from their iPad®, iPhone®, or iPod® touch. Doctors can take their device to meetings, the bedside, or consults to easily share images with other doctors or physicians. The application uses Apple’s native navigation controls such as pinching to zoom and swiping to pan the screen. A measurement tool allows the user to make 2D and 3D measurements, which is useful when developing a diagnosis. Users can also calibrate the screen’s contrast to ensure they are getting the highest quality image, which was an FDA requirement. The application can be synched to the MIM Cloud so data is pushed to the mobile device without being connected to the hospital’s network. That means physicians can review cases while at home. The user can also start working with the data as it streams to the device via a 3G connection, so he or she does not need to wait for the entire file to download. iPad users can view multiple planes and scans on the device’s larger screen. There is a great video demonstrating this functionality on the Imaging Technology News website. Check it out!
In June 2008, MIM Software’s CTO, Mark Cain, presented the Mobile MIM application at Apple’s World Wide Developer Conference. Soon after the conference, Apple launched the App Store and Mobile MIM was available for download but not for long. It was then quickly yanked from the App Store because the FDA had not approved the application. “Within only a few weeks of submitting, we were contacted by the FDA and told that our app could not be on the app store (despite the fact that it was both free and labeled as “not intended for diagnostic use”) because it served as marketing for a device that was not cleared for marketing. We promptly removed it,” Cain said in an interview with mobihealthnews.com. One year later, MIM resubmitted a 501(k) to the FDA with data from clinical trials. That submission was also denied. Finally, the FDA granted clearance on the third submission, two and a half years after it originally launched with the App Store. Today, it is one of the best healthcare applications on the market. Using the app The MIM Mobile application essentially mobilizes the MIM’s workstation software so doctors can review CT, MRI, and X-ray images in high resolution and make diagnoses right from their iPad®, iPhone®, or iPod® touch. Doctors can take their device to meetings, the bedside, or consults to easily share images with other doctors or physicians. The application uses Apple’s native navigation controls such as pinching to zoom and swiping to pan the screen. A measurement tool allows the user to make 2D and 3D measurements, which is useful when developing a diagnosis. Users can also calibrate the screen’s contrast to ensure they are getting the highest quality image, which was an FDA requirement. The application can be synched to the MIM Cloud so data is pushed to the mobile device without being connected to the hospital’s network. That means physicians can review cases while at home. The user can also start working with the data as it streams to the device via a 3G connection, so he or she does not need to wait for the entire file to download. iPad users can view multiple planes and scans on the device’s larger screen. There is a great video demonstrating this functionality on the Imaging Technology News website. Check it out!
