FDA approves medical-image software for Apple mobile devices
Add diagnosing soft-tissue injuries to online banking, e-mail, video games and thousands of other applications available for the iPad, iPhone and iPod Touch.
The Food and Drug Administration ushered in the era of mobile diagnostic radiology Friday, approving software for viewing images and making medical diagnoses from MRIs and CT, PET and SPECT scans on several of Apple Inc.’s popular hand-held devices.
The FDA reviewed image quality and checked studies with radiologists under variable lighting conditions and determined that the Apple devices running Mobile MIM software offered clear enough images for diagnostic interpretation.
Mobile MIM, made by MIM Software Inc. of Cleveland, includes a safety guide and screen features meant to ensure that a physician can recognize subtle differences in contrast needed to make a proper diagnosis.
It is not approved for reading X-rays or mammograms.
Mobile MIM is approved for use only when there is no access to a workstation, but an FDA spokeswoman, Erica Jefferson, acknowledged that the agency will have no way of knowing whether doctors use mobile devices all the time simply for convenience.
“We don’t know that they won’t,” she said in an e-mail. “The FDA does not regulate practice of medicine, so the physician will have to use their clinical judgment and do what’s best to help them treat their patient.”
MIM Software’s chief technology officer, Mark Cain, said the software would be useful if a radiologist wanted a second opinion about a PET scan from a specialist who was at a conference, on vacation or otherwise away from a workstation.
The software will be used mainly by nonradiologists, such as surgeons or cardiologists, to confirm courses of treatment and explain them to patients, predicted Khan Siddiqui, chairman of the American College of Radiology’s IT and Informatics Committee, who tested early versions of it.
Siddiqui acknowledged a potential for abuse but said the benefits far outweigh the risks. “It’s really game-changing in my opinion,” he said. “It enables us to make decisions at the time of care.”
