Advanced visualization software developer Calgary Scientific has received class II clearance from the U.S. Food and Drug Administration (FDA) for its ResolutionMD software for mobile diagnostic use on all imaging modalities except for mammography.
ResolutionMD is now cleared for diagnosis on mobile devices for imaging modalities including computed radiography (CR), digital radiography (DR), fluoroscopy, angiography, ultrasound, nuclear medicine, endoscopy, and ophthalmology.
Calgary Scientific said it worked closely with a number of radiologists to clinically validate ResolutionMD prior to submitting to the FDA.
The FDA's review of the safety and effectiveness of ResolutionMD found the software to be substantially equivalent to PACS or dedicated diagnostic workstations, giving practitioners access to advanced image storage systems and diagnostic tool sets while they are on the go, the firm said.
