Digital heart and lung health startup eco health announced that it has received FDA 510(k) clearance for an AI-enabled cardiac tool that helps early detect low ejection fraction, a key indicator of heart failure.
Eko Low Emission Rate Tool (ELEFT) Officially received green light from FDA in Marchis an AI-enabled tool that allows healthcare professionals to detect low ejection fraction in 15 seconds during routine exams using the Eko stethoscope.
ELEFT will be added to Eko's SENSORA Cardiac Early Detection Platform. The platform already includes several FDA-cleared algorithms for identifying AFib and structural heart murmurs.
Eko pitches ELEFT as a way to help clinicians spot patients suffering from heart failure during routine physical exams. Affects more than 6.2 million adults in the United States
“FDA clearance of our low ejection fraction AIs is a major milestone in expanding access to early detection of heart disease. „This will help identify millions of people who may be at risk for heart failure who are underserved in communities where PCP offices may not have easy access to echocardiograms,“ Eko's collaboration said Jason Berrett, founder and COO. Mobi Health News on mail.
“Given the potential of AI in clinical applications, this is exactly the type of innovation that will advance our healthcare system, and we could not be more grateful. F.D.A. and our development partners, mayo clinic. ”
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eco scored $65 million in Series C funding In 2020, $30 million extension In 2022.
The company has received numerous 510(k) approvals. Eko noise analysis softwareIt employs algorithms to detect and characterize heart murmurs in adult and pediatric patients.
was previously approved Algorithms to detect atrial fibrillation and heart murmurs And that Duo Portable ECG and Stethoscope.smart stethoscope First received FDA green light in 2015.
Other companies in the technology-enabled heart health space include: cardio signalhas been secured $10 million in Series A funding Based in the UK in January ultromicsin 2022 Secure 510(k) clearance Machine learning-based decision support systems help preserve ejection fraction and detect heart failure.