FDA clears AUM’s diagnostic cardiovascular device
The US Food and Drug Administration (FDA) has cleared AUM Cardiovascular’s acoustic and electrocardiogram (ECG) device called CADence to aid detection of physiological and pathological heart murmurs.
CADence is a non-invasive, radiation-free handheld and reusable device designed to record sounds emitted by a patient’s heart. It has been used in a total of 1,807 patients to date.
The device employs an algorithm and features specific software that crunches the acoustic data presented in the report to enable a physician to analyse the patient's cardiovascular health.
In the previous Turbulence clinical study conducted by the firm, the ECG device is reported to have demonstrated results comparable to a SPECT nuclear stress test for ruling out obstructive coronary artery disease (CAD) in patients suffering from chest pain and with other risk factors.
Turbulence study investigator 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."
The firm is currently working towards obtaining clearance from the FDA to commercialise CADence for CAD detection, with plans to launch additional algorithms that can crunch the acoustic data to detect stenosis, which is characterised by clogged arteries with plaque.
Image: CADence system. Photo: courtesy of PRNewsfoto/AUM Cardiovascular Inc.