Technology | ECG | August 08, 2017

AUM Cardiovascular Receives FDA Approval for CADence ECG Device

Reusable handheld device analyzes acoustic data from patient’s heart to help physicians noninvasively detect physiological and pathological heart murmurs

AUM Cardiovascular Receives FDA Approval for CADence ECG Device

August 8, 2017 — AUM Cardiovascular announced it has received clearance from the U.S. Food and Drug Administration (FDA) for CADence, a non-invasive acoustic and electrocardiogram (ECG) device designed to help physicians detect physiological and pathological heart murmurs.

The reusable, non-invasive, radiation-free handheld device, which is now available in the United States, records sounds originating from the patient's heart. Powered by a proprietary algorithm, special software crunches the acoustic data that is presented in a physician's report. The report allows a physician to determine the state of the patient's cardiovascular health. AUM also plans release of algorithms that crunch the same data to determine if arteries are clogged with plaque, a condition known as stenosis.

For primary care doctors, stenosis is particularly hard to detect because patients do not exhibit noticeable symptoms. Normal screening methods — measuring blood pressure and low-density lipoprotein (LDL) — are not good predictors of stenosis. Computed topography, magnetic resonance imaging and ultrasound can spot stenosis by measuring everything from thickness of artery walls to calcium deposits. But such technologies are expensive.

According to AUM's Turbulence clinical study, CADence performs just as well as a single-photon emission computed tomography (SPECT) nuclear stress test in ruling out obstructive coronary artery disease (CAD) in patients with chest pain and risk factors. AUM is pursuing clearance from FDA to market CADence for detection of CAD.

"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 Jay Thomas, M.D., an interventional cardiologist at Harbor-UCLA Medical Center in Los Angeles, who oversaw the study.

"CADence is an exciting example of how novel technology will revolutionize patient care," Thomas said. "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."

For more information:

Related Content

79-year-old Tony Marovic had a right carotid endarterectomy shortly after discovering a 95 percent blockage of his carotid artery at a health and wellness screening event

79-year-old Tony Marovic had a right carotid endarterectomy shortly after discovering a 95 percent blockage of his carotid artery at a health and wellness screening event. Image courtesy of University Hospitals.

News | Cardiac Diagnostics | October 16, 2019
Health and wellness screenings are more than just nice events for the community – they can save lives. A Mentor, Ohio,...
Pesticide Exposure May Increase Heart Disease and Stroke Risk

Image courtesy of zefe wu from Pixabay

News | Cardiac Diagnostics | October 15, 2019
On-the-job exposure to high levels of pesticides raised the risk of heart disease and stroke in a generally healthy...
World Heart Federation Launches Global Roadmap on Cardiovascular Disease Prevention Among Diabetics
News | Cardiac Diagnostics | September 04, 2019
At the European Society of Cardiology (ESC) Congress 2019 together with the World Congress of Cardiology, the World...
Insomnia Tied to Higher Risk of Heart Disease and Stroke

Image courtesy of the American Heart Association

News | Cardiac Diagnostics | August 19, 2019
People suffering from insomnia may have an increased risk of coronary artery disease, heart failure and stroke,...
Evolutionary Gene Loss May Help Explain Human Predisposition to Heart Attacks
News | Cardiac Diagnostics | July 29, 2019
The loss of a single gene two to three million years ago in our ancestors may have resulted in a heightened risk of...
U.S. Soldiers Have Worse Heart Health Than Civilians
News | Cardiac Diagnostics | June 06, 2019
Active duty Army personnel have worse cardiovascular health compared to people of similar ages in the civilian...
Late Dinner and No Breakfast Worsens Outcomes After Heart Attack
News | Cardiac Diagnostics | May 23, 2019
People who skip breakfast and eat dinner near bedtime have worse outcomes after a heart attack, according to research...
HRS Releases New Expert Consensus Statement on Arrhythmogenic Cardiomyopathy
News | Cardiac Diagnostics | May 14, 2019
The Heart Rhythm Society (HRS) released a first-of-its-kind consensus statement with guidance on the evaluation and...
New Best Practices Help Manage Heart Attack Patients Without Significant Signs
News | Cardiac Diagnostics | April 15, 2019
For the first time in the United States, doctors with the American Heart Association (AHA) have outlined best practices...
Overlay Init