The FDA has approved Calgary Scientific’s medical imaging device, ResolutionMD Mobile, as a mobile diagnostic app for use in the US.
The new technology gives physicians remote access to patient images and reports stored within any healthcare facility, enabling clinical diagnosis of the patient from any location.
Dr James A. Brink, Professor and Chair of the Department of Diagnostic Radiology at Yale University School of Medicine, said: “The ability to view diagnostic quality images on mobile devices promises to speed healthcare delivery, particularly for urgent conditions or after hours.”
The mobile app promises complete security and advanced capabilities through minimal bandwidth, even on 3/4G wireless. The technology also ensures that patient image data cannot be lost or stolen, and no highly sensitive or confidential patient data is ever retained on the device.
Dr Byron Osing, CEO and Chair of Calgary Scientific, said: “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," added Dr Osing.
Non-diagnostic versions of the app are already licensed under OEM agreements with global leaders in medical imaging and information technology.
The software has also been approved by Health Canada, has acquired the CE Mark for distribution in the EU, and is available on Apple iPhone and iPad devices.
Calgary Scientific is a provider of accessible, advanced visualisation solutions in medical imaging and web, mobility and collaboration enablement technologies, used to help industries achieve secure access with their existing technology.