Eko Devices wins FDA nod for portable cardiac monitor

Eko Devices said today that its Duo portable cardiac device won FDA clearance. The hand-held system combines a digital stethoscope with an electrocardiogram to give cardiologists insight into their patients’ daily cardiac function. The Duo device wirelessly pairs with Eko’s app to allows for remote monitoring and diagnosis by a healthcare practitioner. “Eko Duo’s consumer-friendly design can help transform how clinicians monitor heart health in-person or virtually,” Dr. John Chorba, a cardiologist at UC San Francisco, said in prepared remarks. “We need powerful tools which heart failure patients can use to improve self-care and communicate troubling findings with an expert.” Eko also said it is developing machine-learning algorithms to work with Duo to detect and alert patients, as well as their caregivers, of troubling cardiac data. “Cardiology programs are looking for ways to deliver hospital-quality healthcare at home” Dr. Ami Bhatt said. Bhatt is the director of outpatient cardiology & the Adult Congenital Heart Disease Program at Massachusetts General Hospital. “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. Robust toolkits for caring for patients in the community will hopefully lead to more appropriate healthcare utilization through continuous rat...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Food & Drug Administration (FDA) Patient Monitoring Regulatory/Compliance ekodevices Source Type: news