While MIM beat them to it by about seven months, Calgary Scientific just announced that the United States Food and Drug Administration (FDA) had granted it clearance to market its medical imaging application, ResolutionMD Mobile, as a mobile diagnostic app in the US. 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 only this past February.
The ResolutionMD mobile app is cleared to run on iPhone and iPad devices. It already has the greenlight from Canada's regulatory body, Health Canada and has a CE Mark for distribution in Europe.
ResolutionMD Mobile had other "non-diagnostic" versions, which were previously distributed through original equipment manufacture agreements with other companies. (This may be a reference to Sprint, which has said it had a partnership with Calgary Scientific.)
Last September Calgary Scientific announced plans to offer ResolutionMD Mobile through Sprint to provide the app to physicians who own HTC EVO 4G devices -- assumedly this was the non-diagnostic version of the offering. The HTC EVO 4G, which launched in June 2010, was the first phone Sprint has offered for its new 4G network. Calgary Scientific has also partnered with Siemens, Viatronix and Sentinelle Medical to distribute ResolutionMD.
Here's what Calgary Scientific says makes its solution different:
"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."
More in the press release below:
PRESS RELEASE -- Calgary Scientific Inc. has received clearance from the United States (US) Food and Drug Administration (FDA) to market its industry-leading medical imaging application, ResolutionMD™ Mobile, as a mobile diagnostic application, in the US. 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 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 uniquely 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 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 quality images on mobile devices promises to speed healthcare delivery, particularly for urgent conditions or after hours," says James A. Brink, MD Professor and Chair, Department of Diagnostic Radiology at Yale University School of Medicine.
"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. "We believe that Calgary Scientific has set a very high comparative technology standard in the medical IT industry with the ResolutionMD Mobile solution. As the industry clearly understands, lost or stolen patient data is a critical issue in the Medical IT sector, with regular announcements of significant HIPAA 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 Osing.
ResolutionMD Mobile incorporates many advanced capabilities including:
Interactive 2D, MIP/MPR and 3D 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.
About Calgary Scientific, Inc.
Calgary Scientific is dedicated to providing advanced web-enablement, mobility enhancement, multi-party, real-time collaboration, and advanced visualization solutions. These are used in industries seeking secure access and use of their data or graphics-intensive applications, while using their existing systems and all communications infrastructure bandwidths. All of these products demonstrate leading-edge web, mobile, and collaboration enablement capabilities made possible with the unique power of PureWeb® Calgary Scientific strives to be the premier leader and provider of truly accessible, advanced visualization solutions in the medical imaging market, as well as the industry leaders in web, mobility, and collaboration enablement technologies. For more information on Calgary Scientific, go to www.calgaryscientific.com.
© 2011 Calgary Scientific Inc., ResolutionMD, PureWeb and the Calgary Scientific logo are trademarks of Calgary Scientific. All other third-party company names and products are for identification purposes only and may be trademarks of their respective owners.
SOURCE Calgary Scientific Inc.