February 7, 2011 | 2
A medical smart phone app that allows doctors to view and assess medical images has been approved by the U.S. Food and Drug Administration for the first time. The program, called Mobile MIM, pops CT, PET, MRI and other scans directly to portable screens with sufficient quality to enable clinical decisions, the agency concluded in its Friday announcement.
More than 1,500 health care-related apps are already available for download—for professionals and the untrained alike. And doctors have been using similar web-based services, such as Epocrates, for more than a decade. But this is the first technology for smart phones and tablets to be formally approved by the agency that regulates medical devices.
"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," William Maisel, chief scientist in the agency’s Center for Devices and Radiological Health, said in a prepared statement.
One of the review committee’s concerns about the app, which is approved for use on iPhones and iPads, seemed to be the ease of reading the images if light or screen conditions weren’t just right. The app developers seem to have allayed the agency’s fears by including a subtly shaded shape on the screen to serve as a contrast indicator. "If the physician can identify and tap this portion of the screen, then the lighting conditions are not interfering with the physician’s ability to discern subtle differences in contrast," according to the agency’s statement.
The FDA’s decision to approve the app specifically marks a step toward more hands-on regulation of mobile-based medical technology. With a messy marketplace—where apps range from professional medication dosage recommendations to casual nutrition information—there is not yet a clear tiered framework in which to assess these tools. And as many involved in developing these technologies have pointed out, ruling on an app might not always make sense if the reference data or larger systems behind the apps themselves are not currently regulated.
Image courtesy of iStockphoto/ScottBush
Get 6 bi-monthly digital issues
+ 1yr of archive access for just $9.99