Analytic for Hemodynamic Instability (AHI)

by Fifth Eye  · Based in United States → — Predicting hemodynamic instability earlier than vital signs for proactive patient care.
Cardiology Critical Care Emergency Medicine
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Overview

Fifth Eye’s Analytic for Hemodynamic Instability (AHI) System is an FDA-cleared, AI-driven clinical decision support software designed to continuously monitor adult in-hospital patients for signs of hemodynamic instability. It utilizes real-time, continuous Lead-II ECG data, applying advanced signal processing and machine learning to interpret waveform variations.

The system provides an easy-to-interpret output, often described with ‘traffic-light simplicity’ (red, yellow, or green indicators), to give clinicians a dynamic view of a patient’s hemodynamic status and predict the likelihood of future instability episodes. This predictive capability can offer a significant lead time, reportedly up to 26 hours for the AHI-PI (Predictive Indicator) and 48 minutes for the AHI System, compared to traditional vital sign measurements.

AHI aims to reduce nursing burden, improve patient prioritization, streamline hospital workflow, and enable timely interventions, ultimately preventing adverse events, improving patient outcomes, and reducing hospital costs. It is intended for adjunctive use with other clinical information and not to independently direct therapy.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Real-time clinical analytics based on physiologic waveforms
  • Predicts hemodynamic instability earlier than vital signs (up to 26 hours for AHI-PI)
  • Uses continuous ECG lead II data for analysis
  • AI-driven and machine learning-based technology
  • Clinical decision support software for healthcare professionals
  • Easy-to-interpret visual indicators (red, yellow, green)
  • Reduces nurse surveillance burden and streamlines workflow
  • Integrates with existing in-hospital monitoring platforms (e.g., Sickbay, VitalConnect)
  • Non-invasive patient monitoring
  • Continuously monitors hospitalized patients 18 years or older

Use Cases

  • Early detection of patient deterioration
  • Prevention of adverse events
  • Improvement of patient outcomes
  • Reduction of hospital costs
  • Optimization of clinical staff resource allocation and reduction of nursing burnout
  • Stratification of patients' risk levels

What Physicians Need to Know

Evidence Base
The Analytic for Hemodynamic Instability (AHI) is an AI/machine learning-based software that analyzes Lead-II ECG signals. It leverages the physiological relationship of Heart Rate Variability (HRV), the autonomic nervous system, and the cardiovascular system through continuous ECG lead II analysis.
Clinical Validation Studies
AHI demonstrated high performance in identifying hemodynamic instability with 96% sensitivity and stable patients with 85% specificity. A retrospective study further showed its ability to predict future episodes of hemodynamic instability with high sensitivity and specificity, providing clinically relevant lead times.
Alert Fatigue Management
While general clinical decision support systems (CDSS) face challenges with alert fatigue due to excessive irrelevant alerts, AHI's design aims to mitigate this by providing continuous, non-invasive monitoring and alerting clinicians to patient instability hours before critical events. This focus on early, actionable insights inherently seeks to increase alert relevance and reduce unnecessary warnings.
Differential Diagnosis Support
AHI provides an indication of hemodynamic status to support clinical decision-making, rather than offering broad differential diagnosis support. It is intended as an adjunctive tool to identify patients showing signs of hemodynamic instability, allowing clinicians to increase vigilance and intervene earlier.
Clinical Workflow Integration
AHI is designed for real-time streaming data analysis, providing hemodynamic assessments every two minutes, significantly more frequently than traditional nurse-validated vitals. This enables earlier intervention and aims to reduce attending clinician burden by seamlessly integrating continuous monitoring into existing workflows. Effective integration is crucial for user adoption and improved patient outcomes.
Decision Audit Trail
For AI-based clinical decision support systems, robust audit trails are essential for transparency, verifiability, and accountability. These trails should record system inputs, retrieved evidence, inference steps, and any human overrides with rationale, aligning with principles from evidence-based medicine and trustworthy AI.
Physician Tip

AHI offers a proactive approach to detecting hemodynamic instability, providing continuous, real-time insights from ECG data. Leverage its early warning capabilities to enhance vigilance and initiate interventions sooner, potentially hours before critical events become apparent through traditional vital signs. Remember that AHI is an adjunctive tool; integrate its output with your comprehensive clinical assessment and other patient data for optimal decision-making. While designed to reduce irrelevant alerts, always critically evaluate any alert in the context of the individual patient's condition. Its non-invasive nature makes it suitable for broad application in various in-hospital settings.

AHI is a software as a medical device (SaMD) that integrates by analyzing continuous Lead-II ECG signals from existing physiological monitoring equipment. Successful integration into clinical workflows requires seamless data streaming from monitoring devices and presentation within existing electronic health record (EHR) systems or dedicated displays. Future integrations may expand its applicability across different care settings and potentially incorporate additional physiological data for enhanced predictive capabilities, aligning with its platform potential for broader indications.

Details

Category Cardiology AI, Triage & ER/ICU AI
Pricing Contact vendor — Not specified
DeploymentSoftware as a Medical Device (SaMD) integrated into in-hospital monitoring platforms; accessible via any browser-enabled device.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Analytic for Hemodynamic Instability (AHI) received De Novo authorization (DEN200022) from the FDA on March 1, 2021, classifying it as a Class II prescription Software as a Medical Device (SaMD). A second generation, the AHI System, which includes the AHI Predictive Index (AHI-PI), also received FDA clearance.
Integrations
EHR Not specified
Specialties Cardiology, Critical Care, Emergency Medicine

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Press & Coverage

Arboretum Ventures
Fifth Eye Receives FDA Clearance to Market AHI Systemu2122
Fifth Eye announced FDA clearance to market its second-generation clinical decision support software, the AHI Systemu2122, to hospitals in the United States. The AHI System helps clinicians by providing real-time clinical analytics based on ECG signals to predict hemodynamic instability.
2022-01
BioWorld
Fifth Eye launches ML-based tool to predict hemodynamic instability
Fifth Eye Inc. received de novo authorization from the FDA for its Analytic for Hemodynamic Instability (AHI), a machine learning-based, real-time indicator of patient deterioration, with commercialization beginning March 1, 2021. The device continuously monitors patients using an electrocardiogram (ECG) for signs of deterioration, providing a real-time view of blood flow and instability.
2021-03
University of Michigan Medical School Research
Fifth Eye's AHI-PI Demonstrates Ability to Detect Patient Deterioration Prior to Rapid Response Team Events: New Study Published in PLOS Digital Health
A new study published in PLOS Digital Health demonstrates that Fifth Eye's Analytic for Hemodynamic Instability u2013 Predictive Indicator (AHI-PI) can detect patient deterioration an average of 26 hours before Rapid Response Team events, outperforming traditional vital sign measurements. This AI-driven, FDA-cleared analytic, based on ECG waveforms, shows promise for broader application beyond the ICU.
2024-10
PR Newswire
Fifth Eye's AHI System: Detects shock, patient deterioration hours ahead of vital signs
Fifth Eye showcased its AHI System at HLTH 2023, highlighting its ability to detect patient deterioration hours before vital signs. The AHI System uses AI to interpret ECG waveform signal variations, providing clinicians with more time to intervene and improve patient outcomes.
2023-09
Michigan Medicine
Innovative patient stability technology developed at MCIRCC gets FDA market approval
Fifth Eye Inc., a Michigan Medicine spinoff, received FDA De Novo classification for its Analytic for Hemodynamic Instability (AHI), a noninvasive device that continuously monitors ECG signals to identify signs of hemodynamic decline. This technology, developed at the University of Michigan Center for Integrative Research in Critical Care (MCIRCC), aims to detect patient instability hours before traditional vital signs.
2021-03
Critical Care Explorations (via PMC)
Detection of Hemodynamic Status Using an Analytic Based on an Electrocardiogram Lead Waveform
This retrospective cohort study investigated the Analytic for Hemodynamic Instability (AHI), a novel, noninvasive technology that uses continuous ECG signals to predict hemodynamic instability without direct blood pressure measurement. The study found AHI's sensitivity and specificity for detecting hemodynamic instability to be 96.9% and 79.0% respectively.
2022-05
MedTech Dive
AirStrip Acquires FifthEye's Platform for Predicting Hemodynamic Instability
AirStrip, a provider of clinical surveillance solutions, announced the acquisition of FifthEye, the developer of the FDA-cleared AHI System. The AHI System analyzes non-invasive ECG signals to predict hemodynamic instability before it's apparent in traditional vital signs, enhancing clinical decision-making.
2025-06
FDA
CDRH Premarket Authorizations that Used Real-World Evidence
The FDA lists the Analytic for Hemodynamic Instability (AHI) (DEN200022) by Fifth Eye Inc. as a premarket authorization that used real-world evidence. Hospital data was a primary source of clinical evidence for the De Novo classification, with a prospective validation study conducted at the University of Michigan Medical Center.
2026-06

Videos

Product demos, reviews, and walkthroughs for Analytic for Hemodynamic Instability (AHI).

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Frequently Asked Questions

AHI is designed to integrate with existing electronic health records (EHRs) and bedside monitoring systems, typically through secure APIs. It processes real-time physiological data to provide alerts and insights directly within the clinician's existing interface, aiming to minimize workflow disruption.
AHI would typically seek FDA clearance (e.g., as a Class II medical device) for its intended use in clinical decision support. It adheres to stringent data privacy regulations like HIPAA, employing encryption, access controls, and de-identification protocols to protect patient information.
Unlike traditional monitoring that provides raw data, AHI utilizes advanced algorithms to analyze complex data patterns, predicting instability earlier and offering actionable insights. It aims to move beyond simple thresholds to provide a more nuanced and predictive assessment compared to basic alert systems.
Pricing for AHI often follows a subscription-based model, which can vary based on the number of beds, integration complexity, and included features. Factors like ongoing support, maintenance, and potential customization also contribute to the total cost of ownership.
AHI, like any AI tool, may have limitations related to the generalizability of its training data, potentially leading to biases in specific patient populations or rare conditions. It's crucial to understand its performance characteristics, including false positive and negative rates, and recognize that it is a support tool, not a diagnostic replacement.
Clinical validation studies and trials are essential to demonstrate AHI's effectiveness in improving outcomes such as reduced length of stay, earlier intervention, or decreased mortality. These studies typically compare AHI-guided care against standard care to quantify its impact.
AHI is designed to augment, not replace, a physician's clinical judgment by providing timely, data-driven insights and alerts. Clinicians should interpret AHI's recommendations as additional data points to be considered within the broader clinical context, integrating them with their expertise and patient-specific factors.

Compare Analytic for Hemodynamic Instability (AHI)

VS
Analytic for Hemodynamic Instability (AHI) vs Sleepiz One+
Cardiology AI Adjacent · 65/100
Fifth Eye's AHI System is designed for in-hospital continuous monitoring of adult patients, predicting hemodynamic instability hours before traditional vital signs. Sleepiz One+ is a contactless remote patient…
VS
Analytic for Hemodynamic Instability (AHI) vs EchoNext
Cardiology AI Adjacent · 65/100
Fifth Eye's AHI System focuses on continuous, real-time monitoring of in-hospital patients to predict hemodynamic instability hours in advance using ECG lead II data. In contrast, Pathway Labs'…
VS
Analytic for Hemodynamic Instability (AHI) vs Irregular Rhythm Notification Feature (IRNF)
Cardiology AI Adjacent · 60/100
Tool A (Fifth Eye's AHI System) is designed for continuous, in-hospital monitoring of adult patients to predict hemodynamic instability hours in advance, providing clinical decision support for healthcare…
VS
Analytic for Hemodynamic Instability (AHI) vs Study Watch with Irregular Pulse Monitor
Cardiology AI Adjacent · 65/100
Tool A, Fifth Eye's AHI System, is designed for continuous in-hospital monitoring of adult patients to predict hemodynamic instability hours before traditional vital signs. Tool B, Verily's Study…

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