FDA clears acoustic, ECG device from AUM Cardiovascular to detect heart murmurs

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AUM Cardiovascular has received clearance from the U.S. Food and Drug Administration (FDA) for its acoustic and ECG device to detect heart murmurs.

The CADence is a reusable, non-invasive, radiation free handheld device that records sounds of a patient’s heart. AUM Cadiovascular, based in Northfield, Minnesota, developed a proprietary algorithm to examine acoustic data in a physician’s report.

"The CADence system has the potential to dramatically enhance our ability to rule-out significant coronary artery disease and efficiently triage patients needing additional testing," said Jay Thomas, MD, an interventional cardiologist at Harbor-UCLA Medical Center in Los Angeles, who oversaw the study.

AUM Cardiovascular conducted a clinical study with 1,807 patients, where the CADence system performed as well as SPECT nuclear stress test in regards to coronary artery disease.