Hitachi partner, Calgary Scientific, Receives Class II Clearance from FDA for Resolution MD

Document created by Renee Stacey on Apr 7, 2014Last modified by Renee Stacey on Apr 7, 2014
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Calgary, AB – April 7, 2014 – Calgary Scientific Inc., a company known for creating transformative technology for the medical industry and beyond, announced today their latest Class II clearance from the United States (US) Food and Drug Administration (FDA). The leading enterprise image-viewing solution, ResolutionMD® is now cleared for diagnosis on mobile devices, for all imaging modalities*. Calgary Scientific worked closely with a number of Radiologists at a world renowned healthcare organization to clinically validate the solution prior to submitting to the FDA. This builds upon their previous clearances for diagnosis using web, iOS and Android devices.

“We chose to implement ResolutionMD because it gives us the ability to quickly disseminate the images from our Pediatric Imaging Departments so that clinicians can provide the fastest and best care and treatment to our patients,” said Stuart Royal, M.S., M.D., Radiologist-in-Chief at Children’s Hospital of Alabama. “Their fully accredited, diagnostic image quality and secure solution gives us the flexibility to make clinical decisions from any device type, portable or desktop throughout our healthcare system and off-site.”

The FDA’s safety and effectiveness review of ResolutionMD found it to be substantially equivalent to PACS or dedicated diagnostic workstations, giving practitioners access to advanced image storage systems and diagnostic tool sets on-the-go. Gaining this clearance means a healthcare enterprise, across all departments, can feel confident in using ResolutionMD to perform a clinical diagnosis on web, iOS and Android devices, as it has been through a rigorous testing process, as agreed to by the FDA.

“We are excited to deliver this clearance to the institutions that rely on ResolutionMD to improve patient care”, said Pierre Lemire, President and CTO of Calgary Scientific.  “This is also an important advancement for all our valued partners including those who deliver custom-branded solutions, as they will be added under the Calgary Scientific registration with the FDA.”

About ResolutionMD

ResolutionMD enables doctors to securely view patient images and reports from a wide variety of computers and mobile devices, collaborate with other practitioners and diagnose from any location. Whether you are a single facility or a large healthcare system with tens of thousands of users, ResolutionMD is the best choice for seamless image access across multiple departments. The FDA cleared, Health Canada licensed and CE marked mobile medical diagnosis software can be integrated into any EMR and easily plugs into existing distributed storage systems. ResolutionMD’s federated approach is an important differentiator from other solutions as highly sensitive data is never moved to a device and no additional data storage locations are created. ResolutionMD is published in twelve languages and is currently installed in leading healthcare institutions around the world via a network of more than thirty-five world class healthcare partners. For more information on ResolutionMD, go to www.calgaryscientific.com/resolutionmd. To see the importance of using accredited enterprise viewing software, visit http://offers.calgaryscientific.com/useaccredited.

- See more at: http://www.calgaryscientific.com/news/calgary-scientific-receives-fda-clearance-for-mobile-diagnosis-on-all-modalities/?utm_campaign=Use-Accredited&utm_source=linkedin&utm_medium=social&utm_content=4750338#sthash.daaif71R.dpuf

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