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Posted at 1:24 PM ET, 02/ 4/2011

FDA approves iPhone, iPad app for docs

By Rob Stein

The Food and Drug Administration announced Friday it had approved the first app that doctors can use to view medical images and make diagnoses using an iPhone or iPad.

The app enables doctors to view images produced by diagnostic tests such as CT (computed tomography) scans, MRIs (magnetic resonance imaging) and PET (positron emission tomography) scans.

The app "is not intended to replace full workstations and is indicated for use only when there is no access to a workstation," the FDA said.

"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, the FDA's chief scientist and deputy director for science in the Center for Devices and Radiological Health said in a statement.

The images taken in the hospital or doctor's office are compressed so they can be transferred via a secure network to portable wireless device using software called Mobile MIM, which is made by MIM Software Inc. in Cleveland.

The software "allows the physician to measure distance on the image and image intensity values and display measurement lines, annotations and regions of interest," the FDA said.

Before approving the app, the agency "reviewed performance test results on various portable devices" that measured brightness, image quality, and distortion, the agency said.

"The FDA also reviewed results from demonstration studies with qualified radiologists under different lighting conditions. All participants agreed that the device was sufficient for diagnostic image interpretation under the recommended lighting conditions," the FDA said.

By Rob Stein  | February 4, 2011; 1:24 PM ET
Categories:  FDA, Medical Technology, medical devices  
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