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FDA clears first diagnostic radiology app, Mobile MIM
By Brian Dolan
February 04, 2011
Mobile MIM was one of the very first medical applications to debut in Apple's AppStore when it first launched in 2008, but the
application also has the distinction of being the first medical application pulled from the store because of regulatory concerns. Today
those concerns are over: The US Food and Drug Administration has officially granted the mobile radiology application a 510(k)
clearance.
“The application is the first cleared by the FDA for viewing images and making medical diagnoses based on computed
tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine technology, such as positron emission tomography
(PET)," the FDA stated in a press release this morning. "It is not intended to replace full workstations and is indicated for use only when
there is no access to a workstation.”
MIM's experience is one of the few public accounts of the nuances of FDA regulation of mobile health services. The clearance
some two and a half years later of an app that originally launched with Apple's AppStore is surely a milestone for mobile health.
(Adapted from https://www.mobihealthnews.com)
Segundo o texto, o Mobile MIM
