Calgary Scientific's ResolutionMD Mobile Receives FDA Clearance for Diagnostic Image Viewing on iPhones and iPads
September 27, 2011 – Calgary Scientific Inc. has received clearance from the U.S. Food and Drug Administration (FDA) to market medical imaging application, ResolutionMD Mobile, as a mobile diagnostic application in the United States. With this secure, highly scalable, server-based software solution, physicians 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 non-diagnostic 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 bears the CE mark 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 was then mobile-enabled into a state-of-the-art product, utilizing the power of Calgary Scientific's PureWeb platform technology, which allows ResolutionMD to simultaneously support multiple mobile devices and operating systems. This initial FDA clearance applies to versions of the solution running on Apple iPhone and iPad devices. The mobile app offers unparalleled 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 traditional 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 significantly 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 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 [computed tomography] CT and [magnetic resonance] 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 quality images on mobile devices promises to speed healthcare delivery, particularly for urgent conditions or after hours," says James A. Brink, M.D., professor and chair, department of diagnostic radiology at Yale University School of Medicine.
ResolutionMD Mobile capabilities include:
- Interactive 2-D, MIP/MPR and 3-D advanced visualization
- Anywhere, anytime access to and fully interactive use of MR and CT images
- Supports HIPAA Compliance – User authentication and encrypted communications further protect confidential patient information
- Concurrent support for multiple devices and mobile operating platforms – The solution 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 then near future.
- Ambient Light User Assessment – Provides sample images to the user to assess the viewing suitability of current lighting conditions.
ResolutionMD Mobile is currently available on Apple iPhone and iPad devices through the Apple App Store. A demonstration version (ResolutionMD Mobile Lite) is also available on the Apple App Store, providing access to anonymized patient images. The ResolutionMD Server is available from Calgary Scientific Inc., as well as from its family of global leading OEM partners in medical imaging and information technology.
For more information: www.calgaryscientific.com