Cardiology

Acumen Assisted Fluid Management (AFM) Software Feature

Edwards Lifesciences, LLC

FDA-cleared AI medical device

The adjunctive open loop fluid therapy recommender is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict a patient’s estimated response to fluid therapy. The device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

FDA Submission Metadata

Submission number
K233984
Decision date
August 2024
FDA panel
Cardiovascular
Product code
QMS
Clinical task (npj)
quantification/feature localization
Data modality (npj)
Signals

This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.

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