Calgary Scientific won new FDA clearance for its ResolutionMD system, making medical images from more modalities available for mobile diagnosis.
The new FDA nod adds to existing clearances permitting diagnosis on the web as well as on iOS and Android devices. Calgary can now further market the ResolutionMD system for all of its imaging modalities, with the exception of mammography.
"This is also an important advancement for all our valued partners including those who deliver custom-branded solutions, as they will be added under the Calgary Scientific registration with the FDA," Calgary president and CTO Pierre Lemire said in prepared remarks. "We are excited to deliver this clearance to the institutions that rely on ResolutionMD to improve patient care."
The new FDA clearance was granted based in part on studies which found that review of images via ResolutionMD was equivalent to dedicated diagnostic workstations, Calgary said. The ResolutionMD system allows doctors to access medical images via many computers and mobile devices.
The ResolutionMD won FDA clearance around this time last year to expand to Android devices.