Eko Low EF
Eko Health
Combines a digital stethoscope and single-lead ECG with an algorithm that flags likely reduced ejection fraction during a routine physical examination.
At A Glance
- Manufacturer
- Eko Health
- Medical specialty
- Cardiology
- Clearance route
- FDA authorized
- Year authorized
- 2024
- Modality
- ECG and digital stethoscope
- Role in workflow
- Screening
Moving low-ejection-fraction detection from a 12-lead ECG in a cardiology clinic to a stethoscope in a primary care room is a distribution change more than a technical one, and distribution is usually what determines whether a screening tool matters.
Where It Is Used
- Primary care heart failure screening
- Point-of-care assessment during routine examination
- Identifying patients needing echocardiography
Limitations Worth Knowing
Single-lead signal carries less information than 12-lead, and the same prevalence-dependent positive predictive value problem applies. In a low-risk primary care population most flags will not be confirmed, which has real cost in downstream imaging and patient anxiety.
Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.