AUM Cardiovascular has secured approval from the US Food and Drug Administration (FDA) for its new diagnostic heart device CADence.
The non-invasive acoustic and ECG device has been developed for physicians to detect physiological and pathological heart murmurs.
CADence is a reusable and radiation-free handheld device, which can record sounds originating from the patient's heart.
With the support of an advanced algorithm, the special software is said to crunch the acoustic data that is presented in a physician's report.
The report will help physician to find out the state of the patient's cardiovascular health.
The company is also planning to launch algorithms, which crunch the same data to determine if arteries are clogged with plaque.
CADence operates better than SPECT nuclear stress test in ruling out obstructive coronary artery disease (CAD) in patients with chest pain and risk factors, according to the firm’s Turbulence clinical study.
Los Angeles’ Harbor-UCLA Medical Center interventional cardiologist Dr Jay Thomas said: "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.
"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."
Based in Northfield of Minnesota, AUM Cardiovascular is engaged in the development of non-invasive, acoustic and ECG-based systems to assess cardiovascular disease. – MDBR