Calgary Scientific’s iPhone app receives FDA clearance | Regulatory Roundup

Calgary Scientific’s ResolutionMD mobile got a green light from the FDA for viewing diagnostic images on iPhones and iPads.

The ResolutionMD mobile app was built from existing ResolutionMD software, which recieved FDA clearance in 2006. The app already has the greenlight from Canada’s regulatory body, Health Canada and has a CE Mark for distribution in Europe.

"The ability to view diagnostic quality images on mobile devices promises to speed healthcare delivery, particularly for urgent conditions or after hours," Yale Medicine’s James Brink said in prepared remarks.

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In a study published in May, two neuro-radiologists compared stroke diagnosis, one used a diagnostic workstation and the other using Calgary Scientific’s ResolutionMD app. The study showed that using the ResolutionMD app is between 94 percent – 100 percent accurate in diagnosing acute stroke, compared to a medical workstation.

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