News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Image quality of wireless device screens may already be good enough for basic digital pathology use

When the U.S. Food and Drug Administration (FDA) recently cleared—for the first time—a mobile application (app) for Radiology Diagnostics, it set the scene for similar mobile apps to gain FDA clearance for use in evaluating digital pathology images.

Both pathologists and clinical laboratory managers are likely to be intrigued with how swiftly mobile computing technology can adapted for use with healthcare images. Earning the honors as the first mobile app to be cleared by the FDA for use with radiology images is the Mobile MIM software, developed by MIM Software, Inc. of Cleveland, Ohio.

This application software enables physicians to view computed tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography (PET) images on iPads, iPhones, and iPod Touches.

The FDA deemed the images to be of high enough quality to be used for medical diagnostics and cleared the app in February.

(Diagnostic measurements taken using Mobile MIM. Image courtesy of MIM Software, Inc.)

(Diagnostic measurements taken using Mobile MIM. Image courtesy of MIM Software, Inc.)

Wireless Technology Becoming More Popular at Point of Care

Hospital physicians are proving most willing to use wireless technology at the bedside. That is one reason why more companies are producing software for handheld wireless devices. Dark Daily covered this important trend from the perspective of clinical laboratories and anatomic pathology groups. Medical laboratories will want to make their lab results available to mobile device users, as described in “Tech-Savvy Doctors are Putting Smartphones and iPads to Work in their Medical Practice.”

Dark Daily provided additional perspectives with “Why Smartphones May Be the Best Business Opportunity in Healthcare,” in which Dark Daily revealed that 80% of all physicians in healthcare would be using some sort of handheld device by the end of 2012.

Though Apple’s iPhones and iPads have a head start, Smartphones and other app-driven portable devices are clearly gaining ground. Until last month, however, the FDA had not cleared a particular app for medical diagnostic usages.

FDA Clearance Seen as Favorable for Digital Pathology Mobile Apps

The FDA considered the clearance of a mobile application for evaluating radiology images to be a noteworthy event. It issued a press release and wrote that the software enables physicians to “measure distance on the image, and image intensity values, and display measurement lines, annotations and regions of interest.”

In its evaluation of Mobile MIM, the FDA measured the resolution (image quality), noise, and the luminance of the transmitted images. Working with qualified radiologists, the FDA determined that Mobile MIM provided adequate enough quality of resolution to be used for medical diagnostics when a full workstation was not available.

“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., M.P.H., Chief Scientist and Deputy Director for Science in the FDA’s Center for Devices and Radiological Health in the FDA’s press release.

The new Mobile MIM software is free to download from Apple’s iTunes App Store and includes sample images for learning purposes. Additional images are free to download at MIMCloud, a free online service that enables physicians and other medical professionals to exchange encrypted medical data.

That the FDA has begun to clear apps for mobile medical devices is a clear indicator that the government is not likely to impede use of wireless technology in healthcare. Further, as mobile device companies continue to improve the resolution and image quality of the screens in their devices, these advances are likely to make it easier for pathologists and other laboratory professionals to use their wireless devices—in combination with mobile apps—to review images when outside the laboratory. In turn, this is likely to help pathologists speed up the time required to provide an answer to the referring physicians.

—Michael McBride

Related Information:

FDA Clears First Diagnostic Radiology Application for Mobile Devices

Mobile MIM has received FDA 510(k) clearance, and is now available in the US Apple App Store


Digital Pathology stories on Dark Daily

The Dark Report: June 2008 – Era of Digitized Pathology Systems Approaches

Executive War College 2011 topic on May 4th: Cutting the Cost and Time to Interface Your LIS with Doctors’ EMRs, SmartPhones, and Ipads