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FDA approves new mobile radiology application

The US Food and Drug Administration has cleared a new mobile radiology application which will allow physicians to view medical images on the iPhone and iPad manufactured by Apple.

The application helps to view images and make medical diagnoses based on computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine technology, such as positron emission tomography (PET).

It is not intended to replace full workstations and is indicated for use only when there is no access to a workstation.

FDA’s Center for Devices and Radiological Health chief scientist and deputy director for science William Maisel 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.

The appropriate portable wireless device via software, Mobile MIM, manufactured by Cleveland-based MIM Software, receives radiology images taken in the hospital or physician’s office in compressed secure network transfer mode.

Mobile MIM allows the physician to measure distance on the image and image intensity values and display measurement lines, annotations and regions of interest.

The FDA reviewed performance test results on various portable devices measured luminance, image quality (resolution), and noise in accordance with international standards and guidelines.

The device includes an interactive contrast test in which a small part of the screen is a slightly different shade than the rest of the screen, including a safety guide.