Acumen Hypotension Prediction Index (HPI) Feature Software

by Edwards Lifesciences  · Based in United States → — A first-of-its-kind technology that detects and helps clinicians treat hemodynamic instability.
Anesthesiology Critical Care Emergency Medicine

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Regulatory Status Disclosed

Overview

Acumen Hypotension Prediction Index (HPI) Feature Software Overview

The Acumen Hypotension Prediction Index (HPI) software by Edwards Lifesciences is an advanced, predictive monitoring technology designed to alert clinicians to the likelihood of a patient trending toward a hypotensive event before it occurs. Utilizing machine learning algorithms, the HPI software analyzes complex blood pressure waveform features to provide a unitless score ranging from 0 to 100, indicating the probability of hypotension (defined as mean arterial pressure < 65 mmHg for at least one minute) within a specified timeframe, typically 15 minutes.

This innovative software is integrated into Edwards’ advanced hemodynamic monitoring platforms, such as the HemoSphere system. It is compatible with both invasive arterial line monitoring (e.g., via FloTrac IQ sensor) and, with subsequent FDA clearances, non-invasive monitoring through the Acumen IQ finger cuff.

Beyond simply predicting an event, the Acumen HPI software provides a ‘Relationship View’ screen that offers insights into the potential underlying causes of hypotension, visually arranging hemodynamic parameters by preload, afterload, and contractility. This feature, combined with ‘Smart Alerts’ and ‘Smart Trend’ screens, supports clinicians in making proactive, goal-directed therapeutic decisions to address hemodynamic instability and potentially reduce the incidence, duration, and severity of intraoperative hypotension.

Clinical studies have demonstrated that the use of Acumen HPI software can significantly reduce the duration of intraoperative hypotension and is associated with improved patient outcomes, including a reduced risk of complications such as acute kidney injury and myocardial injury.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Hypotension Prediction Index (HPI) parameter (0-100 score)
  • Smart Alerts and Smart Trend screen for impending hypotensive events
  • Relationship View screen providing insights into preload, afterload, and contractility
  • Machine learning algorithms for predictive analysis of blood pressure waveforms
  • Predicts hypotension up to 15 minutes before an event
  • Demonstrated reduction in incidence, duration, and severity of intraoperative hypotension
  • Compatibility with both invasive (arterial line) and non-invasive (Acumen IQ cuff) monitoring
  • Adjustable Mean Arterial Pressure (MAP) target for hypotension definition
  • Supports goal-directed hemodynamic therapy (GDHT)

Use Cases

  • Proactive management of intraoperative hypotension in surgical patients
  • Early detection of hemodynamic instability in critical care settings
  • Guiding individualized goal-directed hemodynamic therapy
  • Reducing the risk of postoperative complications associated with hypotension (e.g., AKI, MI)
  • Retrospective analysis of hemodynamic data for quality improvement (via Acumen Analytics)

What Physicians Need to Know

Hypotension Prediction Index (HPI)
The HPI parameter, ranging from 0 to 100, indicates the likelihood of a hypotensive event, with higher values signifying increased probability. It is updated every 20 seconds, providing continuous predictive insights.
Real-Time Alert Capability
Smart alerts or HPI high alert pop-ups are triggered when the HPI parameter exceeds 85 for two consecutive 20-second updates or reaches 100, prompting clinicians to review patient hemodynamics. The software can predict hypotension up to 15 minutes before an event occurs.
Root Cause Analysis
A secondary screen provides insights into the potential cause of hypotension by visually organizing hemodynamic parameters related to preload (e.g., Stroke Volume Variation/Pulse Pressure Variation), afterload (e.g., Dynamic Arterial Elastance), and contractility (e.g., Systolic slope dP/dt).
Cardiac Monitoring Integration
The Acumen HPI software integrates with the Edwards HemoSphere advanced monitoring platform. It is compatible with the minimally-invasive Acumen IQ sensor (connecting to an arterial line) and the non-invasive Acumen IQ cuff (finger cuff) for continuous blood pressure and advanced hemodynamic parameter monitoring.
Accuracy and Efficacy
The software uses machine learning algorithms, trained on extensive patient data, to predict hypotension with high accuracy. Studies have shown it can significantly reduce the incidence, duration, and severity of intraoperative hypotension.
Physician Tip

The Acumen HPI software serves as an adjunctive predictive tool, offering early warning of impending hypotension and insights into its potential hemodynamic causes (preload, afterload, contractility). Clinicians should use the HPI parameter as additional quantitative information and always integrate it with a comprehensive review of the patient's complete hemodynamic state before making therapeutic decisions. The Mean Arterial Pressure (MAP) target for hypotension is adjustable, allowing for personalized care. Proactive intervention guided by HPI can lead to reduced duration and severity of hypotensive events.

The Acumen HPI software is part of the Acumen intelligent decision support suite and operates on the Edwards HemoSphere advanced monitoring platform. It requires either the Acumen IQ sensor (for invasive arterial line monitoring) or the Acumen IQ cuff (for non-invasive continuous blood pressure monitoring). The Critical Care product group, including Acumen HPI, is now part of BD (Becton, Dickinson and Company), with Edwards Lifesciences remaining the manufacturer of the products.

Details

Category Cardiology AI, Triage & ER/ICU AI
Pricing Contact vendor — Not publicly available; contact Edwards Lifesciences for pricing information.
DeploymentIntegrated into Edwards Lifesciences HemoSphere advanced monitoring platform.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Received De Novo clearance in March 2018 as an adjunctive predictive cardiovascular indicator. Further 510(k) clearances in June 2021 enabled its use with the non-invasive Acumen IQ cuff, and in June 2023 for adjustable MAP targets.

Integrations
EHR Not specified
Specialties Anesthesiology, Critical Care, Emergency Medicine

What the Web Says

The Acumen Hypotension Prediction Index (HPI) Feature Software is a predictive monitoring tool designed to alert clinicians to potential hypotensive events before they occur in surgical and non-surgical patients. It uses machine-learning algorithms to analyze cardiovascular vital signs and arterial waveforms, providing a score (0-100) indicating the likelihood of hypotension. The software aims to improve patient care by enabling proactive intervention and reducing the incidence, duration, and severity of intraoperative hypotension.

Overall: Positive

Strengths

  • Predicts hypotensive events up to 15 minutes before they occur, allowing for proactive intervention.
  • Significantly reduces the incidence, duration, and severity of intraoperative hypotension.
  • Provides intelligent decision support by offering insights into the root cause of hypotension through a secondary screen displaying hemodynamic parameters.
  • Demonstrates superior predictive abilities compared to traditional hemodynamic parameters like cardiac output and mean arterial pressure.
  • Can be used with both invasive (arterial line) and non-invasive (Acumen IQ cuff) monitoring solutions.
  • Supported by multiple clinical studies and randomized controlled trials showing its effectiveness.

Limitations

  • Requires an arterial line for optimal use and is only compatible with Edwards' minimally invasive hemodynamic monitoring solutions.
  • The HPI parameter should not be the sole basis for therapeutic decisions; a review of patient hemodynamics is recommended.
  • Limited evidence on patient outcomes and for use in intensive care patients.
  • No published evidence to support claims of cost savings from reduced adverse outcomes or length of stay.
  • One retrospective study in major aortic surgery did not find a statistically significant reduction in hypotension burden, though clinically relevant trends were observed.
  • May be associated with significantly more time with elevated Mean Arterial Pressure (MAP) in some cases.

Based on reviews from: tctmd.com, Edwards Lifesciences, NICE, accessdata.fda.gov, ClinicalTrials.gov, PMC, HT Medical Devices, PubMed, MDPI, YouTube, BD Learning Academy

Last updated: 2026-07-21

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Press & Coverage

Federal Register
Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Predictive Cardiovascular Indicator
This regulatory announcement from the FDA classifies the Acumen Hypotension Prediction Index (HPI) Feature Software as an adjunctive predictive cardiovascular indicator, a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events.
2022-02
accessdata.fda.gov
DEN160044.pdf
This FDA document details the De Novo classification request for the Acumen Hypotension Prediction Index (HPI) Feature Software, submitted by Edwards Lifesciences, LLC on September 26, 2016. It outlines the device's indications for use, stating it provides physiological insight into a patient's likelihood of future hypotensive events and associated hemodynamics for operating room patients receiving advanced hemodynamic monitoring.
2016-09
MedTech Dive
AI in medtech is booming. Track new devices here.
This article from MedTech Dive tracks FDA-authorized AI technologies, listing the Acumen Hypotension Prediction Index (HPI) Feature Software by Edwards Lifesciences as a cardiovascular, adjunctive predictive cardiovascular indicator authorized on March 16, 2018.
2025-05
PMC - NIH
Artificial intelligence in cardiology: Hope for the future and power for the present
This peer-reviewed article discusses the role of artificial intelligence in cardiology and mentions the Acumen Hypotension Prediction Index (HPI) Feature Software by Edwards Lifesciences as a De Novo device authorized on March 16, 2018, for detection support for future hypotensive events.
2022-09
Cardiology AI
Acumen Hypotension Prediction Index (HPI) Feature Software vs HeartFlow Analysis
This comparison highlights the Acumen HPI as a 'first-of-its-kind' predictive monitoring tool that uses machine learning to forecast hypotensive events up to 15 minutes in advance, enabling proactive intervention in critical care.
unknown
PMC - NIH
The landscape of artificial intelligence-enabled medical devices in the EU and the US intended for intensive care units
This study on AI-enabled medical devices in ICUs mentions the Acumen Hypotension Prediction Index (HPI) Feature Software (DEN160044) as a device providing clinicians with insights into the likelihood of future hypotensive events and associated hemodynamics in surgical and non-surgical patients receiving advanced hemodynamic monitoring.
unknown
RadAI Slice
Cerebral Autoregulation Index (CAI) Algorithm | FDA Radiology AI Device - X-ray Interpreter
This article lists the Acumen Hypotension Prediction Index (HPI) Feature Software as a De Novo device from 2018, among other devices from Edwards Lifesciences.
2024-10
Frontiers
AI-enhanced non-invasive monitoring of critical biochemical analytes in perioperative care: a review of signal processing and clinical applications
This review article references the FDA's De Novo classification request for the Acumen Hypotension Prediction Index Feature (DEN160044) from 2018, highlighting its role in non-invasive monitoring.
unknown

Videos

Product demos, reviews, and walkthroughs for Acumen Hypotension Prediction Index (HPI) Feature Software.

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Frequently Asked Questions

The Acumen HPI software uses machine learning to analyze arterial pressure waveforms in real-time, generating a score (0-100) that indicates the likelihood of a hypotensive event within the next 5-15 minutes. It is intended for use in surgical and non-surgical patients receiving advanced hemodynamic monitoring, providing early warning to clinicians.
The Acumen HPI software has received CE Mark approval in Europe and a De Novo request grant from the U.S. FDA, designating it as an adjunctive predictive cardiovascular indicator. It is restricted to prescription use and is considered additional quantitative information, not intended to solely direct therapeutic decisions.
Limitations include the risk of overtreatment due to false alarms, potential for inappropriate fluid or vasopressor administration, and complications from unnecessary interventions if clinicians rely solely on the HPI parameter. The software is an adjunctive tool, and therapeutic decisions should always be based on a comprehensive review of the patient's hemodynamics and clinical judgment.
While Acumen HPI is noted as a first-of-its-kind predictive monitoring software, other research teams are developing personalized algorithms and AI-driven devices for hypotension prediction. Standard care typically involves conventional intermittent non-invasive cuff measurements or continuous invasive arterial catheter monitoring, with clinicians reacting to observed blood pressure drops.
Acumen HPI software is generally offered on a subscription model, and specific pricing information requires direct contact with the vendor, Edwards Lifesciences. While studies suggest potential economic benefits like reduced hospital length of stay, these must be weighed against the implementation costs of the technology and associated medical devices.
The HPI algorithm was developed using machine learning on large datasets of arterial waveforms, with initial validation studies showing high sensitivity and specificity. However, future developments may include improved algorithms trained on more diverse patient populations to enhance generalizability, as some concerns exist regarding selection bias in initial validation studies.

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