FDA Clears First AI to Aid Heart Failure Detection During Routine Check-ups | BioSpace

Updated

Eko Health announces FDA clearance for its Low EF detection AI. 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.

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.

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