Acumen Assisted Fluid Management (AFM) Software Feature

by Edwards Lifesciences  · Based in United States → — Optimize fluid administration with predictive decision support.
Anesthesiology Critical Care

Contact for pricing
Regulatory Status Disclosed

Overview

The Acumen Assisted Fluid Management (AFM) Software Feature by Edwards Lifesciences is an advanced AI-enhanced tool designed to optimize fluid administration in surgical patients. It utilizes a sophisticated rules-based algorithm and machine learning to provide individualized fluid recommendations.

Integrated with the Acumen IQ sensor and displayed on the HemoSphere monitor, Acumen AFM software predicts a patient’s fluid responsiveness by analyzing their hemodynamic data and past responses to fluid administration. This predictive decision support helps clinicians keep patients within an optimal fluid range, adapting throughout a procedure by learning from the patient’s response to each analyzed fluid bolus.

The software automatically tracks volume administration and flow rate in real time, offering suggestions regarding the patient’s physiological condition and estimated response to fluid therapy. It is intended to simplify the implementation of fluid management protocols and perioperative goal-directed therapy (PGDT), aiming to reduce complications associated with both insufficient and excessive volume administration.

Acumen AFM is part of the broader Acumen intelligent decision support suite, which also includes tools for hypotension prediction and retrospective data analysis.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Predicts patient fluid responsiveness using an algorithm and machine learning
  • Provides individualized fluid recommendations
  • Automatically tracks volume administration and flow rate in real time
  • Learns from patient's response to fluid boluses to optimize future recommendations
  • Integrates with Acumen IQ sensor for continuous hemodynamic monitoring
  • Displayed on the HemoSphere advanced monitor
  • Offers predictive decision support for proactive fluid management
  • Aids in the implementation of perioperative goal-directed therapy (PGDT)

Use Cases

  • Optimizing fluid administration in surgical patients
  • Supporting perioperative goal-directed therapy (PGDT)
  • Proactive management of hemodynamic instability
  • Reducing complications from insufficient or excessive fluid volume
  • Enhancing clinician decision-making for fluid therapy

What Physicians Need to Know

Key Capabilities
Acumen AFM software optimizes fluid administration by providing individualized bolus recommendations based on machine learning algorithms that predict fluid responsiveness. It automatically tracks volume administration and flow rate in real-time and adapts its recommendations by learning from the patient's response to each fluid bolus. The software offers physiological insights into estimated fluid therapy responses and can be configured with user-defined fluid strategies (e.g., desired 10%, 15%, or 20% increase in stroke volume). It also includes a Prompt Reclassifier algorithm to refine fluid bolus suggestions.
Clinical Utility
The tool aims to keep surgical patients (18 years and older requiring advanced hemodynamic monitoring) in an optimal fluid range, proactively managing hemodynamic instability and reducing variability in fluid administration. It simplifies the implementation of perioperative goal-directed therapy (PGDT). Studies have shown that fluid boluses recommended by Acumen AFM software resulted in desired stroke volume increases more often than clinician-initiated boluses. It is intended for adjunctive use, providing suggestions rather than independently directing therapy.
Integration Options
Acumen AFM software is unlocked by and requires an Acumen IQ sensor, which connects to any existing radial arterial line. The software's insights are displayed on the HemoSphere monitor. It is part of the broader Acumen software suite, which also includes Acumen Hypotension Prediction Index (HPI) and Acumen Analytics software for retrospective data analysis.
Compliance Status
The Acumen AFM software feature was originally granted De Novo (DEN190029) by the FDA on November 13, 2020, and is classified as a Class II medical device. Software verification and validation activities adhere to standards such as ANSI/AAMI/IEC 62304 and FDA guidance documents. Its sale, distribution, and use are restricted to prescription use.
User Experience
The software is designed to simplify complex goal-directed fluid management algorithms. Clinicians are guided by the software's suggestions but retain full control over fluid administration. The user interface allows for setting desired fluid strategies and surgical approaches (e.g., open or laparoscopic/prone), and provides notifications regarding fluid volume delivered. Users can pause or stop an AFM session as needed.
Support Quality
Edwards Lifesciences (now BD for the Critical Care product group) provides 24/7 technical support and a commitment to high levels of customer service for seamless product implementation and ongoing use. Comprehensive clinical education resources are also available.
Implementation Complexity
Implementation requires the Acumen IQ sensor and HemoSphere monitor. The system is designed to ease the complexity of implementing perioperative goal-directed therapy (PGDT) by integrating hemodynamic variables and continuously analyzing fluid responsiveness.
Evidence Base
A multicenter, prospective, single-arm cohort evaluation involving 330 adults undergoing moderate- to high-risk noncardiac surgery demonstrated that 66% of software-recommended fluid boluses achieved desired stroke volume increases, compared to 41% of clinician-initiated boluses. Smaller studies have shown improved preload-independent states, higher sublingual microvascular flow, and lower arterial lactate with Acumen AFM-guided therapy. The performance in predicting fluid responsiveness is measured by the response rate of followed recommendations. An ongoing multicenter study (NCT06011187) is further assessing patient outcomes.
Physician Tip

Acumen AFM software serves as an adjunctive decision support tool; always integrate its recommendations with comprehensive patient assessment and other clinical data. While the software provides individualized fluid bolus suggestions and tracks administration, the ultimate decision for fluid management remains with the clinician. Pay attention to the user-defined fluid strategies and surgical approach settings to ensure the algorithm aligns with your clinical goals. Utilize the available clinical education and 24/7 technical support for optimal implementation and ongoing use.

The Acumen AFM software is an integral part of the Edwards Lifesciences (now BD Critical Care) Acumen suite, requiring the Acumen IQ sensor and HemoSphere monitor for full functionality. The Acumen IQ sensor connects to existing radial arterial lines, providing continuous hemodynamic data. The system also integrates with Acumen Analytics software for retrospective data review, allowing for a comprehensive understanding of patient hemodynamics across various monitoring platforms.

Details

Category Pharmacology & Dosing AI, Surgical AI
Pricing Contact for pricing — Custom pricing available upon request.
DeploymentOn-premise software feature running on the HemoSphere advanced monitor, enabled by the Acumen IQ sensor.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status 1 AI-estimated

The Acumen Assisted Fluid Management (AFM) Software Feature received FDA De Novo classification (DEN190029) on November 13, 2020. It subsequently received 510(k) clearance (K233984) on August 2, 2024, for the addition of the AFM Prompt Reclassifier algorithm. It is intended for use in surgical patients 18 years of age or older who require advanced hemodynamic monitoring, providing physiological insight into their estimated response to fluid therapy.

Integrations
EHR Not specified
Specialties Anesthesiology, Critical Care

What the Web Says

The Acumen Assisted Fluid Management (AFM) Software Feature by Edwards Lifesciences is a real-time clinical decision support tool that uses machine learning to provide individualized fluid recommendations for surgical patients aged 18 and above who require advanced hemodynamic monitoring. It analyzes cardiovascular vital signs and past responses to fluid boluses to predict a patient's estimated response to fluid therapy, aiming to optimize fluid administration and potentially reduce risks of fluid overload or inappropriate treatment. The system operates as an adjunctive, open-loop tool, meaning clinicians make the final therapeutic decisions based on the software's suggestions and other patient information.

Overall: Positive

Strengths

  • Provides individualized fluid recommendations based on machine learning and patient's past responses.
  • Assists clinicians in optimizing fluid administration, potentially reducing risks of fluid overload or inappropriate treatment.
  • Demonstrated to improve fluid responsiveness and increase stroke volume more effectively than conventional clinician-guided methods.
  • Automatically tracks volume administration and flow rate in real-time.
  • Can lead to patients spending more time in a preload-independent state during surgery.
  • May lead to lower arterial lactate at the end of major liver surgery compared to more restrictive fluid strategies.

Limitations

  • The device does not independently direct therapy; clinicians must review and make final decisions.
  • Requires integration with compatible sensors, specifically the Acumen IQ sensor.
  • Clinical studies have noted a high rate of declined/discarded suggestions (approximately 50%).
  • The effectiveness relies on how clinicians interpret and integrate recommendations into practice, with a potential learning curve.
  • Limited data available on how AFM is adopted in routine clinical practice and how clinician interaction evolves over time.
  • No specific reviews or opinions from healthcare IT, tech reviewers, Reddit, G2, or Capterra were found for this specific software feature, though general Acumen software is listed on Capterra.

Based on reviews from: Innolitics (FDA 510(k) summary), Edwards Lifesciences (Product page, Setup guide), accessdata.fda.gov (DEN190029 decision summary), More standardised u2013 and more individualised: How AI-guided decision support can enhance goal-directed fluid therapy (Article), Edwards Lifesciences, LLC (FDA correspondence), Implementation and learning curve in AI-assisted fluid management during abdominal oncologic surgery: a retrospective observational study - PMC, Assisted Fluid Management Software Guidance for Intraoperative Fluid Administration (Journal Article), Enhancing Fluid Management in High-Risk Surgeries Through Decision Support Systems (Article), Assisted Fluid Management Software Guidance for Intraoperative Fluid Administration - PubMed, BD (Acumen IQu2122 Sensor product page), Capterra (General Acumen software listing), ClinicalTrials.gov (Study protocol)

Last updated: 2026-07-18

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Press & Coverage

Medtech News
Artificial Intelligence and Machine Learning in Software as a Medical Device (SaMD)
The Acumen Assisted Fluid Management (AFM) Software Feature by Edwards Lifesciences, LLC received FDA approval in August 2024. The AFM software uses AI algorithms to optimize fluid management in patients, particularly during surgical procedures, by analyzing real-time hemodynamic data to support personalized fluid therapy decisions.
2025-05
Innolitics
Acumen Assisted Fluid Management (AFM) Software Feature (DEN190029) u2014 FDA 510(k)
The Acumen AFM software feature is intended for use in surgical patients aged 18 and above who require advanced hemodynamic monitoring, offering suggestions regarding the patient's physiological condition and estimated response to fluid therapy. The clinician makes the final decision to administer a fluid bolus based on a review of the patient's hemodynamics.
unknown
510k Monitor
DEN190029: Acumen Assisted Fluid Management (AFM) Software Feature - 510k Monitor
The Acumen Assisted Fluid Management (AFM) Software Feature received FDA 510(k) clearance on November 13, 2020, with Edwards Lifesciences as the applicant. It is classified as an Adjunctive Open Loop Fluid Therapy Recommender under Class II.
2020-11
Federal Register
Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Open Loop Fluid Therapy Recommender - Federal Register
The FDA classified the adjunctive open loop fluid therapy recommender, which includes the Acumen Assisted Fluid Management (AFM) Software Feature, into class II (special controls) effective September 5, 2024. This classification followed Edwards Lifesciences' De Novo classification request received on June 4, 2019.
2024-09
FDA
510(k) Premarket Notification - FDA
Edwards Lifesciences, LLC submitted a 510(k) Premarket Notification for the Acumen Assisted Fluid Management (AFM) Software Feature, identified under regulation number 870.5600 and product code QMS.
2026-06
PMC (PubMed Central)
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting - PMC
The Acumen Assisted Fluid Management (AFM) Software Feature, with FDA 510(k) clearance K233984, is listed as an 'Other' type of device for fluid management optimization in critical care in a study of machine learning-enabled medical devices authorized by the FDA in 2024.
2025-12
YouTube (Edwards Lifesciences)
HemoSphere Monitor Product Overview - YouTube
The HemoSphere monitor, featuring machine learning and predictive algorithms, offers intelligent decision support for managing pressure and flow, and delivers advanced pressure, flow, and tissue oximetry insights. The Acumen Assisted Fluid Management (AFM) software feature is not included on the Viewfinder remote app, which is intended as a visual support aid.
2023-02

Videos

Product demos, reviews, and walkthroughs for Acumen Assisted Fluid Management (AFM) Software Feature.

View all on YouTube

Frequently Asked Questions

Acumen AFM software integrates with advanced hemodynamic monitoring devices, specifically the HemoSphere monitor and Acumen IQ sensor, to provide real-time, individualized fluid recommendations. It uses machine learning to predict fluid responsiveness based on a patient's hemodynamic data and past responses to fluid boluses, aiming to streamline decision-making during surgery.
Acumen AFM software received De Novo clearance (DEN190029) from the FDA on November 13, 2020, for use in surgical patients 18 years of age and older who require advanced hemodynamic monitoring. As a medical device software, it is expected to adhere to strict data security protocols and HIPAA regulations to ensure the confidentiality and integrity of patient health information.
Acumen AFM differentiates itself by using machine learning to predict fluid responsiveness and provide individualized bolus recommendations, learning from the patient's responses over time. Studies have shown that AFM-guided fluid challenges were more often associated with desired increases in stroke volume compared to clinician-initiated challenges, improving adherence to goal-directed fluid therapy protocols.
While specific pricing models are not detailed in public search results, similar advanced medical software often involves subscription fees, per-patient charges, or a one-time licensing fee with ongoing maintenance. Hospitals should consider both the direct software cost and potential savings from improved patient outcomes, reduced complications, and optimized resource utilization.
Acumen AFM's algorithms factor in both population-level data and individual patient responses, aiming to become more accurate and individualized over the course of surgery. While AI algorithms can have limitations or biases based on training data, clinicians retain the ultimate decision-making authority for fluid administration, assessing the patient holistically before accepting or declining recommendations.
Comprehensive training programs are typically provided to ensure clinicians are proficient in using Acumen AFM, covering its features, interpretation of recommendations, and integration into daily practice. Setup guides are available, and ongoing technical support and clinical education resources are generally offered to address user queries and software updates.
Acumen AFM relies on continuous hemodynamic data from the Acumen IQ sensor and learns from the patient's responses to fluid administration. In situations with incomplete or conflicting data, the system may flag these issues, and the clinician's role is crucial to holistically assess the patient and override or adjust recommendations based on their expert judgment and comprehensive clinical picture.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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