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

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.