MedTech Dive April 4, 2024
The clearance adds to the list of devices the FDA has authorized this year with AI algorithms to detect health conditions.
Dive Brief:
- Eko Health received 510(k) clearance for a stethoscope feature that can detect an indicator of heart failure in routine physical examinations, the company said Tuesday.
- The Food and Drug Administration clearance covers artificial intelligence that expands the capabilities of Eko’s Sensora Cardiac Early Detection Platform for the detection of low ejection fraction (EF), when the heart pumps too little blood from the left ventricle.
- Eko sees the tool improving the detection of heart failure by making the identification of low EF in 15 seconds part of routine stethoscope exams performed in primary care settings.
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