Calgary Scientific’s ResolutionMD Mobile receives FDA clearance

Calgary Scientific announced that it has received
clearance from the United States 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 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.

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.

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,” Peterson

“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,” said Byron Osing, chief executive officer and chair, Calgary

By Team
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