Non-Invasive ECG Device Gets FDA Clearance
AUM Cardiovascular announced that the Food and Drug Administration (FDA) has granted clearance for CADence, a new non-invasive acoustic and electrocardiogram (ECG) device for the detection of physiological and pathological heart murmurs.
CADence is a reusable, radiation-free handheld device that records the sounds coming from the patient's heart. Its proprietary algorithm processes the acoustic data and produces a report for the physician to help determine the patient's cardiovascular condition. The device can help rule-out obstructive coronary artery disease (CAD) in 20 minutes.
A different algorithm to determine stenosis in the arteries is anticipated to launch in the future. Conventional screening methods such as blood pressure and low-density lipoprotein (LDL) are not accurate predictors of stenosis and technologies such as computer topography, MRI, and ultrasound are expensive.
Clinical data from the Turbulence study (n=1,807) showed CADence had comparable performance to a SPECT nuclear stress test in excluding obstructive CAD in patients with chest pain and risk factors. "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, who oversaw the study.
CADence is now available for order.
For more information call (612) 799-2511 or visit AUMcardio.com.