Edwards Lifesciences, LLC

Name: AI Device Index: FDA-listed AI-enabled medical devices
Creator: AI Device Index
License: https://creativecommons.org/licenses/by/4.0/

3 AI-enabled medical devices from Edwards Lifesciences, LLC on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

Decision	Number	Device	Company	Panel
2024-08-02	K233984	Acumen Assisted Fluid Management (AFM) Software Feature	Edwards Lifesciences, LLC	Cardiovascular
2023-07-26	K231038	Global Hypoperfusion Index (GHI) Algorithm	Edwards Lifesciences, LLC	Cardiovascular
2018-03-16	DEN160044	Acumen Hypotension Prediction Index (HPI) Feature Software	Edwards Lifesciences LLC	Cardiovascular

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