Fierce Biotech: Eko Secures FDA Clearance for Stethoscope AI To Catch Low Ejection fraction

Summary: Eko Health has secured a groundbreaking clearance from the FDA for an artificial intelligence program that can capture a key indicator of heart performance through its digitally enhanced stethoscopes.

 

Developed in collaboration with the Mayo Clinic, Eko's AI can detect cases of low ejection fraction—a primary sign of heart failure.

Heart failure is typically split between patients with reduced ejection fraction, a condition known as HFrEF, and those with preserved levels, with a complete diagnosis typically requiring a specialized ultrasound exam. Eko estimates more than 3 million people in the U.S. may have HFrEF, with many going untreated.

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