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
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
“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.