Calgary Scientific receives 510(k)

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Advanced visualization developer Calgary Scientific said that its ResolutionMD Cardiac suite of applications, including calcium scoring and coronary artery analysis, has received 510(k) clearance from the U.S. Food and Drug Administration.

According to the Calgary, Alberta-based firm, The ResolutionMD Cardiac suite provides screening, identification and quantification of coronary artery disease through disease-specific workflows delivered on a standard desktop or laptop computer.

The company said the system can be utilized by radiologists, cardiac specialists, or technologists to generate a report in under three minutes. Scored images and reports can be saved to a PACS, electronic medical record, or practice management system for collaboration with a referring physician, communication with the patient, and accurate maintenance of patient records.

ResolutionMD Cardiac Calcium Scoring is now commercially available directly from Calgary Scientific and its distribution partners. The Coronary Artery Analysis application is scheduled for beta release later this quarter, the company said.