Mobile App Receives FDA Clearance for Diagnostic Image Viewing on Smart Phones, Tablets

A new medical app (application) ensures the security of confidential patient diagnostic images and information.

Calgary Scientific, Inc. (Calgary, Alberta, Canada) has received clearance from the United States (US) Food and Drug Administration (FDA) to market its medical imaging application, ResolutionMD Mobile, as a mobile diagnostic application, in the United States. With this secure, highly scalable, server-based software solution, physicians located anywhere can rapidly access, view, and interact with patient images and reports stored within any healthcare facility, and render a clinical diagnosis using their mobile devices. Prior nondiagnostic versions of this product are currently distributed and licensed under original equipment manufacturer (OEM) agreements with global leaders in medical imaging and information technology. In addition to the recent FDA clearance, ResolutionMD Mobile has also been licensed by Health Canada and it bears the CE marking for distribution in Europe.

The ResolutionMD mobile product was purpose-built from the existing ResolutionMD software, which first received FDA clearance in 2006. ResolutionMD Mobile utilized the power of Calgary Scientific’s PureWeb platform technology, which allows ResolutionMD to support simultaneously multiple mobile devices and operating systems. This initial FDA clearance applies to versions of the solution running on Apple (Cupertino, CA, USA) iPhone and iPad devices.

The mobile app offers excellent performance, advanced capabilities, and complete security, utilizes 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 conventional mobile-device rendered software, which requires that data to be sent to the mobile device. The flexible, highly scalable, and easily installed environment of ResolutionMD Mobile expands the delivery of Calgary Scientific's image rendering technologies to empower healthcare organizations, physicians, and patients to view images and reports, provide considerably enhanced levels of patient care, and reduce healthcare system costs.

“We worked very closely with the FDA to identify and address the challenge of delivering the advanced visualization and integrated PACS [picture archiving and communication system] functionality of our ResolutionMD server to various mobile devices,” said Kyle Peterson, director of regulatory and corporate affairs of Calgary Scientific. “Extensive bench testing results and reads performed by practicing radiologists using typical but highly challenging cases for CT [computed tomography] and MR [magnetic resonance] 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 quality images on mobile devices promises to speed healthcare delivery, particularly for urgent conditions or after hours,” stated James A. Brink, MD, professor and chair, department of diagnostic radiology at Yale University School of Medicine (New Haven, CT, USA).

“This is a landmark moment for the Calgary Scientific organization and its family of global and regional OEM and other partners,” said Dr. Byron Osing, chief executive officer and chair, Calgary Scientific. “As the industry clearly understands, lost or stolen patient data is a critical issue in the medical IT [information technology] sector, with regular announcements of significant HIPAA [Health Insurance Portability and Accountability Act] compliance fines being levied and legal settlements in the tens of millions of dollars. 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,” stated Dr. Osing.

ResolutionMD Mobile incorporates many advanced capabilities including: Interactive two-dimensional (2D), maximum intensity projection/ multi-planar reformat (MIP/MPR), and 3D sophisticated visualization and anywhere, anytime access to and fully interactive use of MR and CT images. The app also supports Health Insurance Portability and Accountability Act (HIPAA) compliance provides user authentication and encrypted communications further protect confidential patient information. The concurrent support for multiple devices and mobile operating platforms enables ResolutionMD Mobile capabilities on devices such as the Apple iPhone and iPad, as well as Android devices.

Future versions of the server-based software solution will support an expanded list of mobile devices and operating systems, and supplementary applications to the FDA for clinical diagnostic imaging approval on those devices other than the iPhone and iPad will occur in the near future. The ambient light user assessment provides sample images to the user to assess the viewing suitability of current lighting conditions.

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