Company profile

Edwards Lifesciences, LLC

Edwards Lifesciences, LLC has 3 AI-enabled medical devices on the FDA list. The first decision was on March 16, 2018 and the most recent on August 2, 2024 (Acumen Assisted Fluid Management (AFM) Software Feature). Its most common review panel is Cardiovascular (3 devices).

3AI devices
2018First decision
2024Latest decision
1Specialties

Per year

2018: 12023: 12024: 1
201820232024
Edwards Lifesciences, LLC AI devices per year: 2018 1, 2023 1, 2024 1

By specialty

  • Cardiovascular3

Timeline

  1. Acumen Assisted Fluid Management (AFM) Software Feature · Cardiovascular · QMS
  2. Global Hypoperfusion Index (GHI) Algorithm · Cardiovascular · QNL
  3. Acumen Hypotension Prediction Index (HPI) Feature Software · Cardiovascular · QAQ