Eko Health Receives FDA Approval for Low Ejection Fraction Detection AI

Eko Health has received the US FDA approval for its Low Ejection Fraction (Low EF) detection AI.

The Low EF AI will be added to Eko’s SENSORA Cardiac Early Detection Platform, the latest advancement to the platform which already features FDA-cleared algorithms to identify AFib and structural heart murmurs, often an indicator of valvular heart disease. When Low EF is detected in a primary care exam with SENSORA, access to life-extending treatment can be expedited with a referral to the cardiology department for thorough diagnostic testing and treatment evaluation.

For the first time, U.S. healthcare providers can now detect Low EF, a key heart failure indicator, in 15 seconds using an Eko stethoscope during a routine physical examination. This leap in early detection marks both a significant medical innovation and a new era in the detection of cardiovascular disease.

With Eko’s Low EF AI, we’ve transformed the icon of medicine into an AI-powered heart failure early detection tool that can help improve access to care for millions of patients, at a fraction of the time and cost of echocardiography. It’s been a privilege to work alongside Mayo Clinic in this groundbreaking endeavor,” said Connor Landgraf, co-founder & CEO of Eko Health.

en_GBEnglish (UK)