Calgary Scientific won 510(k) clearance from the FDA for its ResolutionMD app for Androids smartphones.
The app is designed to allow physicians to diagnose medical images on their Android phones.
Calgary won an FDA nod in 2011 for the iPhone- and iPad-compatible versions of the app.
"We are excited to deliver this clearance to the institutions that rely on ResolutionMD to improve patient care," president & CTO Pierre Lemire said in prepared remarks. "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."
"This is a huge step forward in making advanced mobile healthcare applications available on a broader range of devices," added Dr. Alec Megibow, president of the 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."
ResolutionMD is a revolutionary imaging solution that is transforming the medical industry, making 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. Highly sensitive 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.
Calgary said the clearance is its 6th Class II green light since 2006 from the federal watchdog agency. The ResolutionMD app has also garnered CE Mark approval in the European Union and is licensed by Health Canada, according to a press release.
