FDA approves image diagnostic app for Apple devices
Add diagnosing soft tissue injuries to online banking, e-mail, video games and thousands of other applications available on Apple Inc.'s iPads, iPhones and iPod Touches.
The Food and Drug Administration Friday ushered in the era of mobile diagnostic radiology, approving software for viewing images and making medical diagnoses from MRIs and CT, PET and SPECT scans on several of Apple’s popular hand-held devices.
The FDA reviewed image quality and checked studies with radiologists using the devices 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 the 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 has no way of knowing if doctors are using mobile devices all of the time simply for the sake of convenience or saving time.
“We don’t know that they won’t,” Jefferson said. “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 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 in such scans who was at a conference, on vacation or otherwise removed from a workstation.
Cain said Mobile MIM downloads image files onto the Apple device -- which can take a minute or more depending on the size of the file -- but once on the unit, the user can shift quickly among multiple images.
Mobile MIM will be used mainly by non-radiologists 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 the software.
Siddiqui acknowledged a potential for abuse, but said the benefits far outweigh that risk. “It’s really game-changing in my opinion. It enables us to make decisions at the time of care.”
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