Aum Cardiovascular said today that it won 510(k) clearance from the FDA for its Cadence device, which is designed to detect heart murmurs.
Cadence works by applying an algorithm to the acoustic signature of heart murmurs in the primary care setting, allowing physicians to diagnose the condition without resorting to expensive CT, MRI or ultrasound scans.
“A primary care doctor is unlikely to refer patients to pricey specialty clinics, especially if the patient doesn’t show any outward signs of the disease,” founder & CEO Marie Johnson said in prepared remarks. “Cadence offers clinicians a low-cost, effective way of helping to spot heart disease before it’s too late.”
Northfield, Minn.-based Aum said the device has been used on 1,807 patients and performed as well as SPECT nuclear stress testing in a clinical trial of obstructive coronary artery disease.
“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 of L.A.’s Harbor-UCLA Medical Center, principal investigator for Aum’s Turbulence study. “Cadence is an exciting example of how novel technology will revolutionize patient care. 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 20 years.”
Aum said it’s developing algorithms designed to detect stenosis and plans to pursue another FDA clearance for the detection of coronary artery disease.