ResolutionMD given FDA clearance for diagnostic medical image viewing on Android devices

22 April 2013

Canadian company Calgary Scientific Inc has received clearance from the US FDA for its ResolutionMD software that displays diagnostic medical images on Android devices.

The software makes it possible for doctors to securely view patient images from a wide array of computers and mobile devices, collaborate with other practitioners and produce high quality medical diagnosis from any location in real time.

“This is a huge step forward in making advanced mobile healthcare applications available on a broader range of devices,” said Alec J. Megibow, MD, MPH, FACR, President, Society of Abdominal Radiology. “We see the market now beginning to understand the importance of mobile viewing solutions, which are playing an increasingly critical role in helping practitioners deliver better patient care and opening creative ways to deliver high level interactive educational content.”

Patient information is never transferred or retained on the device, as is the case with other mobile device imaging software. A Mayo Clinic 2012 study showed that radiologists using ResolutionMD Mobile versus a traditional PACS workstation were able to access CT scans of stroke victims 24% faster saving an average of eleven minutes per patient. This is very significant with stroke diagnosis as every second counts in making a difference toward patient recovery.

“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 our valued partners as their custom branded solutions will be added under the Calgary Scientific registration with the FDA.”

 “Our extensive validation process which involves both lab testing as well as comparative reads was built on the protocol we established with the FDA when we first obtained clearance for ResolutionMD Mobile on iOS,” said Kyle Peterson, Director, Regulatory and Corporate Affairs of Calgary Scientific.

This is the sixth Class II FDA clearance that Calgary Scientific has received for the software since 2006. ResolutionMD Web received FDA clearance in 2009, followed by clearance for iPhone and iPad in 2011. It is also CE marked for distribution in Europe and licensed by Health Canada.