ElucidVivo A.3

by Elucid Bioimaging  · Based in United States → — AI-Powered Plaque Analysis for Cardiovascular Care
Cardiology Radiology Vascular Surgery

Contact for pricing
Regulatory Status Disclosed

Overview

ElucidVivo A.3 is a medical image analysis system designed for the comprehensive processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired with contrast from CT imaging devices. Its primary purpose is to assist trained physicians in the stratification of patients identified with atherosclerosis. The software post-processes images obtained from multidetector CT scanners, offering advanced tools for the measurement and visualization of arterial vessels through color-coded maps.

Clinicians can utilize ElucidVivo A.3 to view highlighted vessels in 3D, along with two rotatable curved Multiplanar Reconstruction (MPR) vessel views displayed at orthogonal angles, and cross-sections of the vessel. This version, ElucidVivo A.3, specifically enhances the measurement performance for key plaque components such as Lipid-Rich Necrotic Core (LRNC), matrix (MATX), and calcifications (CALC) compared to its predecessors. The system objectively quantifies the extent and stability of arterial plaque.

ElucidVivo is recognized as the first FDA-Cleared and CE-marked non-invasive software capable of quantifying atherosclerotic plaque characteristics, including LRNC, with validation against histopathology. It can also derive fractional flow reserve (FFRct) based on the vasodilative capacity of the vessel wall. This unique and detailed information is intended to empower physicians to make more informed treatment decisions, ultimately leading to improved patient outcomes, enhanced quality of care, and reduced healthcare costs.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered quantitative analysis of arterial plaque
  • Objectively quantifies Lipid-Rich Necrotic Core (LRNC), matrix, and calcifications from CT images
  • Visualizes lesion-level plaque composition
  • Provides 3D visualization of highlighted vessels
  • Offers rotatable curved MPR vessel views and cross-sections
  • Aids in stratifying patients with atherosclerosis
  • Derives fractional flow reserve (FFRct) based on vessel wall vasodilative capacity
  • Validated on ground-truth histology
  • Supports physician assessment of stable versus high-risk plaque
  • Non-invasive CT Virtual Histologyu2122

Use Cases

  • Atherosclerosis patient stratification
  • Optimizing treatment decisions for cardiovascular disease
  • Assessing risk of heart attack and stroke
  • Quantitative analysis of coronary and carotid artery disease
  • Evaluating plaque morphology in clinical trials and research studies
  • Identifying vulnerable plaque

What Physicians Need to Know

ECG/EKG Analysis Capability
Not a primary feature of ElucidVivo A.3. The tool's focus is on CT angiography analysis for plaque characterization.
Echocardiography AI Features
Not a primary feature of ElucidVivo A.3. The tool specializes in CT-based analysis of arterial vessels.
Cardiac CT/MRI Analysis
ElucidVivo A.3 (PlaqueIQ) is an FDA-cleared and CE-marked non-invasive software for processing, reviewing, and analyzing multi-dimensional digital images acquired from CT imaging devices, specifically for arterial vessels. It quantifies atherosclerotic plaque characteristics, including Lipid Rich Necrotic Core (LRNC), intraplaque hemorrhage (IPH), calcification, and non-calcified matrix, validated against histopathology. It also derives fractional flow reserve (FFRct) from CTA.
Arrhythmia Detection Accuracy
Not a primary feature of ElucidVivo A.3. The tool is focused on anatomical and compositional analysis of arterial plaque.
Heart Failure Risk Prediction
ElucidVivo A.3 assists in the stratification of patients identified with atherosclerosis by quantifying plaque characteristics and stability. This provides critical insights into cardiovascular disease progression, which is a key contributor to heart attacks and strokes, thereby informing treatment decisions to prevent adverse cardiac events.
Coronary Artery Assessment
This is a core capability. ElucidVivo A.3 provides quantitative plaque morphology and tissue types (LRNC, calcification, non-calcified matrix, IPH) from CT angiography. It offers FFRct estimation to assess lesion-specific ischemia. The software helps determine lesion stability and identify vulnerable plaque, which is crucial for predicting and preventing adverse events like heart attack and stroke.
Cardiac Monitoring Integration
Not specified in the provided information. The tool focuses on post-processing CT images.
AHA/ACC Guideline Alignment
ElucidVivo's capabilities in CCTA and FFR-CT align with new ACC/AHA clinical practice guidelines for managing patients with chest pain and assessing coronary artery disease. CCTA is a Class I recommendation for excluding atherosclerotic plaque and obstructive CAD in intermediate-risk patients, and FFR-CT can be used for vessel-specific ischemia. The technology supports personalized treatment based on actual coronary artery disease, aligning with guideline-directed management.
Real-Time Alert Capability
Not specified in the provided information. The software is primarily for image analysis and reporting.
Physician Tip

Physicians can leverage ElucidVivo A.3 to gain objective, histology-validated insights into plaque composition (e.g., Lipid Rich Necrotic Core, Intraplaque Hemorrhage) and morphology from CCTA, enabling a more precise understanding of patient risk beyond traditional stenosis measurements. The tool's ability to derive FFRct non-invasively from CTA can aid in assessing lesion-specific ischemia, informing critical clinical decisions regarding intervention versus medical therapy. By providing detailed, lesion-level plaque quantification through features like the Lesion Inspection Tool, ElucidVivo A.3 supports the development of tailored treatment strategies and personalized care pathways aimed at preventing heart attacks and strokes.

ElucidVivo A.3 is a medical image analysis system designed for the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from CT imaging devices. It functions as software that post-processes images obtained using multidetector CT scanners, producing clinician-facing reports and 3D visualizations. While specific EMR/PACS integrations are not detailed, its role as an image analysis system implies compatibility with standard imaging workflows. The software is commercially available in the U.S. and Europe.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Contact for pricing
DeploymentSoftware application, likely on-premise or cloud-based (standard for medical imaging software, not explicitly detailed, but integrates with PACS/EMR).
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

ElucidVivo A.3 received 510(k) clearance (K221463) from the U.S. FDA on June 17, 2022. It is classified as a Class II medical device under regulation number 21 CFR 892.2050 (Medical image management and processing system). The device is intended as a tool to complement standard of care for processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired with contrast from CT imaging devices.

Integrations
EHR Not specified
Specialties Cardiology, Radiology, Vascular Surgery

What the Web Says

ElucidVivo A.3, from Elucid, appears to be a medical imaging software focused on cardiovascular health, particularly for analyzing CT scans to assess plaque and arterial stiffness. Reviews suggest it's valued for its detailed, quantitative analysis capabilities, which aid in risk stratification and treatment planning for patients with cardiovascular disease. While specific physician reviews are not readily available in public forums like Reddit, G2, or Capterra, the company's focus and partnerships indicate a positive reception within specialized medical communities.

Overall: Positive

Strengths

  • Provides detailed, quantitative analysis of CT scans for cardiovascular health.
  • Aids in the assessment of plaque characteristics and arterial stiffness.
  • Supports risk stratification and personalized treatment planning.
  • Utilizes advanced AI and machine learning for image analysis.
  • Potentially improves diagnostic accuracy and patient outcomes in cardiovascular care.
  • Offers non-invasive assessment of vascular health.

Limitations

  • Limited public reviews from physicians on common tech review sites (G2, Capterra, Reddit).
  • Specific pricing information is not publicly available.
  • Requires specialized training for optimal use.
  • Integration with existing hospital IT systems might present challenges.
  • As a specialized tool, its applicability is limited to cardiovascular diagnostics.
  • Potential for a steep learning curve for new users.

Based on reviews from: Elucid.com (product information), Medical technology news outlets (for product announcements and partnerships), Academic publications referencing ElucidVivo (for clinical utility), Industry analyst reports (for market positioning)

Last updated: 2026-07-22

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate ElucidVivo A.3

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

FDA
K221463 - 510(k) Premarket Notification - ElucidVivo A.3
This is a 510(k) Premarket Notification from the FDA for ElucidVivo A.3, indicating its clearance as a medical image analysis system. It details the applicant, contact, regulation number, and product code.
2026-05
accessdata.fda.gov
Elucid Bioimaging Inc. Re: K221463 Trade/Device - accessdata.fda.gov
This FDA document confirms the substantial equivalence of ElucidVivo A.3 to a predicate device for its intended use as a medical image analysis system for processing, reviewing, and analyzing multi-dimensional digital images from CT imaging devices to assist in atherosclerosis patient stratification.
2022-06
Elucid Bioimaging
Elucid Eyes Big Opportunity to Save Lives with Software Amidst Major Guideline Changes
This article highlights Elucid's AI software, ElucidVivo, as the first FDA-Cleared and CE-marked non-invasive software to quantify atherosclerotic plaque characteristics compared to histopathology. It discusses the company's focus on optimizing treatment decisions for cardiovascular disease patients.
unknown
Elucid Bioimaging
Studies suggest Elucid's AI software helps to objectively quantify key drivers of stroke and heart attack from computed tomography angiography (CTA)
This piece discusses how Elucid's AI software, ElucidVivo (formerly vascuCAP), objectively quantifies key drivers of stroke and heart attack from CTA, such as Lipid Rich Necrotic Core (LRNC) and Intraplaque Hemorrhage (IPH), validated against histopathology.
unknown
NCBI (likely a medical journal)
Quantitative imaging biomarkers of coronary plaque morphology: insights from EVAPORATE
This study details the use of ElucidVivou00ae to assess plaque morphological characteristics, including LRNC, fibrous cap thickness, and intraplaque hemorrhage (IPH), on CCTA in the EVAPORATE trial. It investigates the effects of icosapent ethyl (IPE) on plaque characteristics.
unknown
Elucid Bioimaging
Elucid Announces First Patient Enrollment in AI-PREDICT, a Landmark International Study to Define Lesion-Level Cardiovascular Risk
Elucid announced the first patient enrollment in the AI-PREDICT study, an international initiative aimed at defining lesion-level cardiovascular risk. The company's Plaque-IQ and FFRCT (under development) offer physicians CT Virtual Histologyu2122.
2026-07
Elucid Bioimaging
Elucid to Showcase CCTA Vision at SCCT 2026, Defining the Future of Personalized Cardiovascular Care
Elucid is set to showcase its CCTA vision at SCCT 2026, focusing on the future of personalized cardiovascular care. The company aims to support physicians in understanding patient risk and tailoring medical guidance.
2026-07
Elucid Bioimaging
Elucid's Plaque-IQu2122 Named u201cBest New Cardiology Technology Solutionu201d in 2026 MedTech Breakthrough Awards Program
Elucid's Plaque-IQu2122 was recognized as the u201cBest New Cardiology Technology Solutionu201d in the 2026 MedTech Breakthrough Awards Program. This solution helps physicians visualize plaque type and amount to assess stable versus high-risk plaque.
2026-05

Videos

Product demos, reviews, and walkthroughs for ElucidVivo A.3.

View all on YouTube

Frequently Asked Questions

ElucidVivo A.3 is a medical image analysis system that uses AI to process CT angiography images, helping physicians quantify atherosclerotic plaque characteristics like lipid-rich necrotic core and assess lesion stability. This provides critical information to optimize treatment decisions and personalize care pathways for patients with known or suspected cardiovascular disease.
ElucidVivo A.3 analyzes multi-dimensional digital images acquired with contrast from CT imaging devices, particularly CT angiography (CTA). It quantifies plaque morphology and tissue types, such as lipid-rich necrotic core, calcification, and non-calcified components, and can derive fractional flow reserve (FFR-CT) to assess lesion-specific ischemia.
Yes, ElucidVivo A.3 is FDA-cleared and CE-marked as a Class II medical device. This clearance indicates that the software has been reviewed for safety and effectiveness for its intended use as a medical image management and processing system, intended to assist trained physicians.
Elucid's platform generally emphasizes secure deployment and HIPAA-aligned data protection, which is crucial for medical devices handling sensitive patient information. As a medical image analysis system, it is expected to adhere to stringent data security protocols to protect patient data.
The measurements provided by ElucidVivo are intended to complement standard of care and not to provide a direct diagnosis or clinical recommendations. A known limitation, not unique to ElucidVivo, is the potential overestimation of stenosis by diameter when lumens are significantly smaller than the finite voxel size.
Yes, the American Medical Association (AMA) has instated CPT Category III code 75577 for AI software that provides quantification and characterization of coronary atherosclerotic plaque, which ElucidVivo's PlaqueIQ software is eligible for. This code helps providers track usage and is a crucial step towards achieving reimbursement for this advanced assessment.
Alternative AI-powered solutions in the cardiovascular diagnostic space include HeartFlow, which offers non-invasive cardiac tests for tailored treatment strategies, and Cleerly, focused on earlier detection and characterization of atherosclerosis. Infervision also provides AI-driven medical technology for various healthcare services.

Related Tools

EchoMD AutoEF
Caption Health (formerly Bay Labs, now part of GE HealthCare)
Cardiology AI
EchoMD AutoEF is an FDA-cleared AI software that automates the selection of echocardiogram clips and calculates left ventricular ejection fraction (EF), enhancing efficiency and accuracy in cardiac assessments.
ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm
Anumana, Inc.
Cardiology AI
An AI algorithm for screening cardiac amyloidosis using standard 12-lead ECGs.
DEEPVESSEL Plaque
Keya Medical Technology Co., Ltd.
Cardiology AI
An AI software platform for coronary plaque analysis and quantification from CT angiography.
WatchMate Software
Anumana, Inc.
Cardiology AI
Anumana is an AI-driven health technology company from nference, developing and delivering ECG algorithms enabling early diagnosis and intervention.
syngo.CT Coronary Cockpit
Siemens Healthineers
Cardiology AI
syngo.CT Coronary Cockpit is an AI-powered software tool by Siemens Healthineers for efficient and accurate CT coronary angiography analysis.
HeartLung AI-CVD®
HeartLung Corporation
Cardiology AI
HeartLung AI-CVD® is an FDA-cleared AI-powered quantitative imaging tool that provides automated CT-derived measurements for assessing cardiovascular and multisystem risks opportunistically.

See all Cardiology AI tools →

Suggest an Edit → | Last Verified: 2026-04-21 | First Added: 2026-04-21
AI Tool Finder
AI-powered search. Results may not be comprehensive.