Aum Cardiovascular, a start-up company based in Northfield, announced Tuesday that it has received permission from the U.S. Food and Drug Administration to start selling a handheld digital stethoscope that pairs remotely with an artificial-intelligence system to help clinicians analyze acoustic and electrical data for signs of heart murmurs in patients with chest pain.
The device, called Cadence, can be used to identify sounds associated with conditions like heart valve disease, congestive heart failure and obstructive coronary artery disease, Aum’s website says. The device is intended to be used in a clinical setting.
Using Cadence costs $100 or less and takes about 20 minutes to get results back. The relatively simple setup and low cost mean it can be used by clinicians in less-populated regions, and on patients who may be paying out of pocket for the test.
Company founder Marie Johnson compared it to a nuclear stress test, which involves injecting radioactive dye into the patient’s blood stream and then using either drug therapies or exercise like jogging on a treadmill to see how well the heart is working.
A nuclear stress test can cost between $1,000 and $13,000, and many Medicare patients have trouble accessing such a test because of a lack of specialists in their area and unprofitable payment rates for hospitals. The less-costly Cadence test will be used in some cases to identify patients who would benefit from a full nuclear stress test.
“We are going to launch [the Cadence device] in Minnesota, and then I want to take it to Mississippi, because there are [about] 600 cardiologists in the state of Mississippi, compared to ... 1,200 in New York City alone,” Johnson said. “I want to help everyone. I don’t just want to make this a test for wealthy people, which is really what [the] nuclear stress test is all about. ... A lot of private hospitals won’t even do those on Medicare patients.”
A nuclear stress test is expensive in part because it can be used to positively diagnose disease, whereas the Cadence device is used to rule out potential signs of physiological and pathological heart murmurs.
“All relevant patient information must be taken into consideration before making a diagnosis. The Cadence System is not intended to be a stand-alone diagnostic device. It does not supersede the judgment of the clinician,” the FDA-approved indications for use say.
Dr. Jay Thomas, an interventional cardiologist in California who has overseen clinical testing of the Cadence device, said in a news release that the system can be used to evaluate chest-pain patients and triage those who need additional testing: “The need for something like Cadence is quite obvious considering how we have managed chest-pain testing for the last 20 years.”
The device costs $4,999, including the handheld digital stethoscope and 100 tests. The price is discounted to $3,499 for the next 100 tests, including a new stethoscope. Johnson said work is underway to extend the life of the instruments to more than 100 tests.
A prospective clinical trial sponsored by Aum Cardiovascular involving more than 1,000 patients found that Cadence was equivalent to nuclear stress testing in ruling out coronary artery disease in patients with chest pain and risk factors for the condition.
The company is still in the process of getting FDA clearance to market the device for the detection of coronary artery disease.
“The medical industry is moving to point-of-care, less-expensive and less-invasive testing,” Johnson said. “We answer and address that.”
The Medical Alley Association, a medical technology trade group based in Golden Valley, trumpeted the FDA’s clearance of the device Tuesday.
“Aum Cardiovascular’s FDA approval brings a game-changing technology to patients, while again demonstrating that the epicenter of health innovation is Minnesota’s Medical Alley,” association CEO Shaye Mandle said in an e-mailed statement.