Technology | February 04, 2011

FDA Clears First Diagnostic Radiology Application for Mobile Devices?

February 4, 2011 – A new mobile radiology application cleared today by the U.S. Food and Drug Administration (FDA) will allow physicians to view and make a diagnosis from medical images on the Apple iPhone and iPad. 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 said the application is not intended to replace full workstations and is indicated for use only when there is no access to a workstation. However, the application’s clearance will likely be the first of many, as physicians are rapidly adopting iPads as a replacement for traditional clipboards. The device offers a mobile workstation to access and enter information for patient records, images and test results. At the Radiological Society of North America (RSNA) 2010 meeting in December, the event was unofficially dubbed “the year of the iPad” due to the vast number of vendors who were showing new iPad applications to access and manipulate radiology images.

“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,” said William Maisel, M.D., MPH, chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health.

Radiology images taken in the hospital or physician’s office are compressed for secure network transfer, then sent to the appropriate portable wireless device via software called Mobile MIM. Mobile MIM, manufactured by Cleveland-based MIM Software Inc., allows the physician to measure distance on the image and image intensity values and display measurement lines, annotations and regions of interest.

In its evaluation, the FDA reviewed performance test results on various portable devices. These tests measured luminance, image quality (resolution) and noise in accordance with international standards and guidelines. The FDA also reviewed results from demonstration studies with qualified radiologists under different lighting conditions. In an FDA-issued press release, it said all participants agreed that the device was sufficient for diagnostic image interpretation under the recommended lighting conditions.

The display performance of mobile devices can experience significant variations in luminance levels even between mobile devices of the same model. The Mobile MIM application includes sufficient labeling and safety features to mitigate the risk of poor image display due to improper screen luminance or lighting conditions. 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. If the physician can identify and tap this portion of the screen, then the lighting conditions are not interfering with his or her ability to discern subtle differences in contrast. In addition, a safety guide is included within the application.

Outside of the United States, Mobile MIM is available in 14 languages.

For more information: www.mimsoftware.com

Related Content

New ASNC SPECT Imaging Guideline Addresses Advances in Myocardial Perfusion Imaging
News | SPECT Imaging | June 21, 2018
The American Society of Nuclear Cardiology (ASNC) has published an update to its 2010 guidelines for single photon...
Epsilon Imaging Demonstrates Strain Imaging Integration for Echo Programs at ASE 2018
News | Cardiovascular Ultrasound | June 19, 2018
Clinical practice, along with guidelines and research, have shown that speckle tracking strain imaging can improve...
FDA Clears Bay Labs' EchoMD AutoEF Software for AI Echo Analysis
Technology | Cardiovascular Ultrasound | June 19, 2018
Cardiovascular imaging artificial intelligence (AI) company Bay Labs announced its EchoMD AutoEF software received 510(...
Wake Radiology Launches First Installation of EnvoyAI Platform
News | Artificial Intelligence | June 13, 2018
Artificial intelligence (AI) platform provider EnvoyAI recently completed their first successful customer installation...
High Prevalence of Atherosclerosis Found in Lower Risk Patients
News | Magnetic Resonance Imaging (MRI) | June 08, 2018
Whole-body magnetic resonance angiography (MRA) found a surprisingly high prevalence of atherosclerosis in people...
PACS and the Road to Reconstruction
Feature | PACS | June 05, 2018 | By Dave Whitney and Jef Williams
The PACS — picture archiving and communication systems — have been in existence for more than 45 years. One of the...
Intelerad Introduces InteleOne Maestro Enterprise Workflow Orchestration Solution
Technology | PACS Accessories | May 31, 2018
Intelerad Medical Systems announced the release of InteleOne Maestro, its new enterprise imaging workflow orchestration...
Konica Minolta Releases New Turn-Around-Time Feature for Exa Workflow
Technology | PACS | May 30, 2018
Konica Minolta Healthcare Americas Inc. will introduce a new worklist feature, Turn-Around-Time (TAT), for its Exa...
Illuminate and Medexprim Partner to Enhance PACS Data Mining
News | PACS | May 30, 2018
U.S.-based Softek Illuminate and the entrepreneurial French firm Medexprim will be combining, distributing and...
Intelerad Launches AI Initiative for Imaging Workflow Intelligence and Analytics
News | Artificial Intelligence | May 29, 2018
Intelerad Medical Systems announced the launch of its artificial intelligence (AI) initiative along with the expansion...
Overlay Init