AUM Cardiovascular receives FDA clearance for diagnostic ECG system

AUM Cardiovascular has received clearance from the Food and Drug Administration (FDA) for its non-invasive acoustic and ECG device. The CADence device uses recorded sounds from a patient's heart and proprietary algorithms to evaluate cardiovascular health.

With the non-invasive handheld device, physicians are able to examine a patient through a report provided by CADence. After measuring recorded sounds from the heart, the device uses algorithm software to compile a complete report, including conditions that are difficult to diagnose with other means.

"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 Dr. Jay Thomas, an interventional cardiologist at Harbor-UCLA Medical Center in Los Angeles, who oversaw the study. "It is a rapid, cost-effective, radiation-free way to evaluate selected patients with chest pain. The need for something like CADence is quite obvious considering how we have managed chest pain testing for the last twenty years."

Researchers enrolled 1,807 patients to test the efficiency of the device. In comparison with SPECT nuclear stress tests, CADence performed just as well in differentiating patients with obstructive coronary artery disease, chest pain and other risk factors.