FDA Grants Clearance to Eko Device’s Digital Stethoscope

The FDA has issued clearance to Eko Devices’ Eko Core, a next generation digital stethoscope. The device wirelessly streams heart sounds to a HIPAA-compliant smartphone app and integrates heart sounds directly into the patient’s electronic health record.

According to the Berkley, Calif.-based company, the stethoscope will help address a cardiovascular disease crisis that affects 1 in 4 people worldwide.

Clinicians can download the Bluetooth-connected mobile app from the Apple App Store. It allows them to view a heart sound waveform, save heart sounds directly to a patient’s electronic health record and securely collaborate with a cardiologist for a second opinion.

University of California, San Francisco’s Department of Cardiology is leading the device’s ongoing clinical trial. — Michael Cipriano