FDA Clears Portable Cardiac Monitoring Device for Use by Clinicians and Patients


The Food and Drug Administration (FDA) has cleared for marketing a new combined digital stethoscope and electrocardiogram (ECG) device called ‘DUO', created by Eko Devices. DUO, a portable cardiac device, wirelessly links to Eko's HIPAA-compliant app which allows clinicians to monitor the patient remotely. 

Since 2010, when the Patient Protection and Affordable Care Act introduced financial penalties for hospitals with the highest readmission rates for heart failure in the first 30 days, efforts have been stepped up to identify those patients who have a likelihood of being readmitted. The manufacturers believe that the device may be able to cut down on unnecessary hospital readmissions. Clinicians can use the device as a screening tool to quickly spot arrhythmias, heart murmurs, and valvular heart disease, while patients prescribed DUO can monitor heart health at home. By accessing patient data through the app, clinicians are able to adjust treatment as needed. 

Related Articles

“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,” said Dr. Ami Bhatt, Director of Outpatient Cardiology at Massachusetts General Hospital. “Robust toolkits for caring for patients in the community will hopefully lead to more appropriate healthcare utilization through continuous rather than episodic outpatient care.”

The DUO device can only be purchased with a prescription from a licensed practitioner.

For more information visit EkoDevices.com.