Digital cardiac and lung disease health startup Eko Health announced it received FDA 510(k) clearance for its AI-enabled cardiac tool that helps with the early detection of low ejection fraction, a key indicator of heart failure.
Eko Low Ejection Fraction Tool (ELEFT), which officially received the green light from the FDA in March, is an AI-enabled tool that allows providers to detect low ejection fraction in 15 seconds during a routine exam using an Eko stethoscope.
ELEFT will be added to Eko’s SENSORA Cardiac Early Detection Platform, which already contains several FDA-cleared algorithms for identifying AFib and structural heart murmurs.
Eko is pitching the ELEFT as a way to help clinicians during a routine physical examination detect patients experiencing heart failure, a condition that affects more than 6.2 million adults in the U.S.
“FDA clearance for our Low Ejection Fraction AI marks a major milestone for expanding access to early detection for heart disease. By bringing them directly into routine preventive exams, we can help identify the likely millions who are at risk of heart failure, especially in underserved communities whose PCP offices might not have easy access to an echocardiogram,” Jason Bellet, cofounder and COO of Eko, told MobiHealthNews in an email.
“When we think about the promise of AI for clinical applications, this is exactly the type of innovation that will push our healthcare system forward, and we couldn’t be more thankful to the FDA and our development partner, Mayo Clinic.”
THE LARGER TREND
Eko scored $65 million in Series C funding in 2020, and announced a $30 million extension in 2022.
The company has received numerous 510(k) clearances, including for its Eko Murmur Analysis Software, which employs an algorithm to detect and characterize heart murmurs in adult and pediatric patients.
It previously received clearance for an algorithm for detecting atrial fibrillation and heart murmurs and its Duo portable ECG and stethoscope. Its smart stethoscope first received the FDA green light in 2015.
Other companies in the tech-enabled heart health space include CardioSignal, which secured $10 million in Series A funding in January, and UK-based Ultromics, which in 2022 secured 510(k) clearance for its machine learning-based decision-support system used to help detect heart failure with preserved ejection fraction.