Health News
First FDA-approved Mobile Radiology App Poised for Daily Use
May 15th, 2011
The clearance process took more than two years, but the first U.S. Food and Drug Administration (FDA)-approved mobile diagnostic radiology application for the iPhone®/iPad® could quickly become part of the daily work routine for radiologists in remote locations.
"I see these devices being a mainstay for radiologists on call away from a clinical workstation," said Keith Dreyer, D.O., Ph.D., vice-chair of radiology for informatics at Massachusetts General Hospital (MGH) and an associate professor of radiology at Harvard Medical School in Boston. "The devices may currently be too limited in functionality and screen size to provide adequate throughput for a heavy case load, but for answering an immediate question, they will be quite adequate for many examination types."
Approved by the FDA in February, the application—the Mobile MIM from Cleveland-based MIM Software™—can be used to view results of CT, MR imaging and PET exams on mobile devices and use those images to make diagnoses. The application is indicated for use only when there is no access to a workstation, according to the FDA.
Technology Forum logoMade for use with Apple products, the new application allows radiology images taken in a hospital or physician's office to be "compressed for secure network transfer then sent to the appropriate portable wireless device," according to the FDA statement.
Although individual facilities have developed similar applications for their own use, the FDA has been hesitant to approve such applications intended for primary diagnosis rather than secondary viewing, according to David Hirschorn, M.D., director of radiology informatics at New York's Staten Island University Hospital. FDA clearance of Mobile MIM should open the floodgates for approval of similar devices from other companies, he said.
"This is the first company to get the FDA's blessing, but there is nothing in this product that is magic," he said. "Other companies are following right behind."
Research Presented at RSNA 2010 Impacts FDA Decision
Mobile Application
The first FDA-approved mobile diagnostic radiol-ogy application for the iPhone®/iPad®, the Mobile MIM from Cleveland-based MIM Software™ can be used to view results of CT, MR imaging and PET ex-ams on mobile devices and use those images to make diagnoses. The approval is expected to open the floodgates for approval of similar devices from other companies.
One of the first medical applications to debut in Apple's AppStore in 2008, Mobile MIM was quickly pulled from the store due to regulatory concerns. In its subsequent evaluation, the FDA tested Mobile MIM's performance on a number of devices, measuring resolution, noise and luminance against international standards and guidelines. After a lengthy review process, the FDA determined that Mobile MIM provided adequate resolution quality to be used for medical diagnostics when a full workstation was not available.
Research validating the efficacy of the mobile app, presented by Dr. Dreyer and other experts at RSNA 2010, was also shared with FDA during its evaluation process, paving the way for approval. "Engineers have done an excellent job of working with the FDA to clear several hurdles around calibration, environmental lighting and security," said Dr. Dreyer, a member of RSNA's RadLex Steering Committee and chair of the American College of Radiology IT and Informatics Committee-Government Relations Subcommittee.
Approved only for CT, MR imaging and PET, the application could easily apply to other radiology modalities including ultrasound, angiography and fluoroscopy, Dr. Hirschorn said. Radiographs, however, are not app-friendly simply because the devices are too small to achieve the contrast and resolution needed to view an X-ray, Dr. Hirschorn said. "Even if the device had a larger screen—which would defeat the purpose entirely—you would still not be able to control the calibration capability," he said.
While calibration and surrounding light are factors with any display device, variables can change more rapidly with handheld devices. For that reason, the app includes an interactive contrast test in which small parts of the screen are a slightly different shade than the rest of the screen in sequence. If the physician can identify and tap these targets on the screen, the lighting conditions won't interfere with the physician's ability to discern subtle differences in contrast, Dr. Hirschorn said. "It's a simple idea but very effective," he said. "If you are able to see the contrast, you know the display is functioning within normal parameters."
FDA approval of the Mobile MIM hinged largely on the effectiveness of this test, Drs. Dreyer and Hirschorn said.
Enormous Potential Tempered by Unknowns
In terms of day-to-day use, the mobile app has considerable potential for clinicians as well as radiologists. That is the case at MGH, where clinicians have embraced the internally developed iPad/iPhone-based mobile electronic health record application that includes access to all medical images with full fidelity, Dr. Dreyer said.
"I see these devices being used extensively, but not exclusively, by ordering clinicians on the move throughout the hospital, clinic and office settings," he said.
Although the app will be useful for remote consultation overall, the technology will be especially beneficial for accessing subspecialty expertise not otherwise available, said Dr. Hirschorn, who also envisions the app enhancing the resident/radiologist on-call partnership. "Off-site radiologists previously had to access a computer in case a resident called," he said. "With this app, the resident can consult the on-call radiologist at any location."
While the app undoubtedly offers benefits, it also plunges the industry into unchartered territory, creating unknowns on a number of fronts, including liability. Problems could arise, for example, if a physician makes a remote diagnosis from a state in which he is not licensed. "Is a lawyer going to make the argument that I rendered care in a state I'm not licensed in?" Dr. Hirschorn asked. "This is all untested."
The application's novel approach to hardware/software integration also breaks new ground, Dr. Dreyer said. "Never before was there a portable device offering a multi-touch user interface system with medical grade display capabilities," Dr. Dreyer said. "It is a new territory for us all, including the FDA, RSNA and ACR."
Nevertheless, Drs. Dreyer and Hirschorn said the application is essentially the tip of the iceberg in terms of technology's evolving role in radiology.
"I feel quite strongly however that in the coming years we will see advances to our industry never before possible, due in large part to these devices and their upcoming competitors," Dr. Dreyer said.
SOURCE: Radiological Society of North America
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