Company profile

Eko Health, Inc.

Eko Health, Inc. has 2 AI-enabled medical devices on the FDA list. The first decision was on March 28, 2024 and the most recent on August 12, 2025 (Eko Foundation Analysis Software with Transformers (EFAST)). Its most common review panel is Cardiovascular (2 devices).

2AI devices
2024First decision
2025Latest decision
1Specialties

Timeline

  1. Eko Foundation Analysis Software with Transformers (EFAST) · Cardiovascular · DQD
  2. Eko Low Ejection Fraction Tool (ELEFT) · Cardiovascular · QYE