FDA approves first medical iPhone app
Posted by: Brian Eastwood
FDA, mHealth, iphone, medical devices, Regulations
The Food and Drug Administration (FDA) has issued its first approval of a medical iPhone app, Bloomberg News reports.
The application, Mobile MIM, comes from Cleveland-based MIM Software Inc. Already available in more than 30 countries, Mobile MIM lets physicians with an Apple Inc. iPhone or iPad view such medical images as computed tomography, or CT, and magnetic resonance imaging, or MRI scans.
The FDA acknowledges that the Mobile MIM medical iPhone app can help physicians make a diagnosis, saying in a statement that “all participants [in the product's evaluation] agreed that the device was sufficient for diagnostic image interpretation under the recommended lighting conditions.”
Taken in context, Mobile MIM’s approval is the latest evidence that, as the health care industry increasingly turns to information technology to improve patient care and efficiency, the FDA intends to broaden its involvement in health IT regulation.
In particular, the agency is drafting stricter medical device regulations (which it is doing for the first time since the 1970s), and considering a new set of electronic health record software regulations in light of serious EHR software glitches.
Even the Mobile MIM approval is not without a caveat: The application should not replace the radiology workstation as the primary way to view medical images, the FDA said. If nothing else, though, the presence of FDA-approved medical iPhone apps in the Apple store should ease the concerns of potential users.
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