Calgary Scientific Gets FDA Nod for Mobile Diagnostic App

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While MIM beat them to the punch by about seven months, Calgary Scientific Inc. announced during AdvaMed 2011 that the U.S. Food and Drug Administration (FDA) had granted the company clearance to market its medical imaging application called ResolutionMD Mobile, as a mobile diagnostic app. The app provides server-based software solution so that physicians can rapidly access, view and interact with patient images and reports stored within any healthcare facility and then render a clinical diagnosis using their mobile devices.

Approval has been slow going. For example, MIM spent close to two years working with the FDA to secure clearance for its diagnostic mobile imaging app, Mobile MIM, after it was featured on-stage at the original Apple event that launched the iPhone’s AppStore in 2008. MIM received FDA clearance just this past February. The ResolutionMD mobile app is cleared to run on iPhone and iPad devices. The device already has the go-ahead from Health Canada and has CE mark for distribution in Europe.

The newest installment from Calgary Scientific is built from the existing ResolutionMD software, which first received FDA clearance in 2006.

According to a press release issued by the company, the mobile app offers security, uses minimal bandwidth and offers strong performance even on 3/4G wireless, and ensures that no highly sensitive or confidential patient information is ever retained on the mobile device. The patient image data cannot be lost or stolen, as in the case of traditional mobile-device rendered software, which requires that data be sent to the mobile device.

“We worked very closely with the FDA to identify and address the challenge of delivering the advanced visualization and integrated PACS functionality of our ResolutionMD server to various mobile devices,” said Kyle Peterson, director of Regulatory and Corporate Affairs of the Calgary, Canada-based firm. Scientific. “Extensive bench testing results and reads performed by practicing radiologists using typical but highly challenging cases for CT and MR were amongst the wide variety of supportive materials and studies submitted to the FDA during the course of this extensive process, which validated the primary diagnostic use of ResolutionMD Mobile.”

The ability to view diagnostic images on mobile devices promises to speed healthcare delivery, particularly for urgent conditions or after hours.

“The FDA clearance of the ResolutionMD solution is a key strategic step forward for the medical IT sector in enabling a high-performance and secure ‘mHealth’ paradigm, as well as ensuring that vast regions of the world that are currently dependent upon wireless connectivity can now leapfrog directly into the realm of advanced medical solutions, without having to first invest billions of dollars in high-speed networks over decades of elapsed time,” said Dr. Byron Osing, Calgary Scientific’s CEO.

In addition to MIM and Calgary Scientific, Health Discovery Corp.launched an iPhone app in July that uses image-based pattern recognition and mathematical algorithms to assess melanoma risk. A pharmacy app from Medco was registered as a Class I medical device earlier this month.