Eko Devices gets FDA nod for its DUO digital stethoscope and ECG combo

The FDA has cleared Eko Devices’ portable cardiac device that combines a digital stethoscope with electrocardiogram (ECG), allowing cardiologists and patients to better monitor heart disease, the company said.

Dubbed the DUO, the compact, handheld device gives physicians and clinicians a screening tool for heart disease patients as part of their home-health kit. The device, which is only available by prescription, is matched with the company’s secure, HIPAA-compliant app that allows for remote monitoring and diagnosis.

Heart disease is the leading cause of death in the U.S., according to the CDC. About $26 billion is spent each year on hospitalization related to heart failure, according to the American Heart Association. Studies have shown that 25% of heart failure patients are readmitted to the hospital within 30 days and 50% are readmitted within six months, the company said.

"Cardiology programs are looking for ways to deliver hospital-quality healthcare at home," Ami Bhatt, M.D., director of Outpatient Cardiology and the Adult Congenital Heart Disease Program at Massachusetts General Hospital, said in a statement. "The ability to capture digital heart sounds and an ECG expands our portfolio of mechanisms to remotely monitor the heart, and brings diagnosis and opportunities for early intervention even further upstream.”

The company also said it is currently working on machine-learning algorithms that can be combined with DUO to alert patients and their care teams of a decline in cardiac function.

Eko’s digital stethoscope enhancement grew out of Skydeck, the University of California-Berkley’s startup accelerator. In 2015, the company received $2 million in funding to boost the development process of the device.