Salix Coronary Plaque

by Artrya Limited  · Based in Australia → — Changing the way the world sees coronary artery disease.
Cardiology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

Artrya Salix Coronary Plaque is an AI-driven, web-based software solution designed to assist medical professionals in the rapid and accurate diagnosis of coronary artery disease (CAD) using Coronary Computed Tomography Angiography (CCTA) data. It provides near real-time, point-of-care assessment of plaque and stenosis, identifying key biomarkers of heart disease, including high-risk low-attenuation plaque, spotty calcification, positive remodeling, and napkin-ring sign. The platform integrates with existing imaging systems to optimize clinical workflows, allowing for analysis, annotation, editing, sharing, triaging, and report generation within a single interface. By leveraging deep learning AI algorithms, Salix Coronary Plaque aims to improve diagnostic accuracy, personalize treatment strategies, and support preventative care, ultimately reducing unnecessary hospitalizations and improving patient outcomes. It is intended as an adjunctive tool to a health professional’s comprehensive review and clinical judgment.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-enabled CCTA analysis
  • Near real-time, point-of-care assessment
  • Detection and quantification of coronary plaque (atherosclerosis)
  • Identification of high-risk plaque features (e.g., low-attenuation plaque, spotty calcification, positive remodeling, napkin-ring sign)
  • Stenosis assessment
  • Quantification of calcifications (calcium scoring)
  • Integrated workflow management
  • Automated report generation (editable)
  • Personalized 3D heart model visualization
  • Web-based, cloud deployment

Use Cases

  • Rapid assessment of chest pain patients
  • Personalized cardiac risk assessment
  • Diagnosis and management of coronary artery disease (CAD)
  • Stratification of patients for preventative care
  • Optimizing clinical workflows and reporting
  • Reducing unnecessary hospitalizations and diagnostic testing

What Physicians Need to Know

Cardiac CT/MRI Analysis
Salix Coronary Plaque is an AI-enabled module that performs near real-time, point-of-care assessment of plaque and stenosis for patients who have undergone a coronary CT angiogram (CCTA). It is a web-based software tool for viewing and analyzing cardiac CT data.
Heart Failure Risk Prediction
The module enables near real-time detection and quantification of high-risk plaque, which is a key predictor of heart attack and contributes to a more personalized cardiac risk assessment.
Coronary Artery Assessment
This tool detects and quantifies coronary artery plaque, including high-risk features such as low attenuation plaque, spotty calcification, positive remodeling, and napkin-ring sign. It also assesses stenosis and quantifies calcifications (calcium scoring).
Cardiac Monitoring Integration
The Salix Coronary Plaque module is embedded within the same user interface as the Salix Coronary Anatomy platform and integrates seamlessly with existing imaging systems and hospital workflows. It is a cloud-based, AI-driven diagnostic tool.
AHA/ACC Guideline Alignment
The tool's focus on identifying non-obstructive plaque aligns with the 2021 AHA/ACC Chest Pain Guideline, which for the first time included non-obstructive plaque in the definition of coronary artery disease. It also standardizes data and reporting based on SCCT guidelines.
Real-Time Alert Capability
The Salix Coronary Plaque module provides assessments in under ten minutes, enabling rapid, point-of-care detection of high-risk plaque and accelerating the triage of chest pain patients.
Physician Tip

Leverage Salix Coronary Plaque for rapid, AI-powered analysis of CCTA scans to precisely detect and quantify coronary artery plaque, including high-risk features often missed by manual methods. This can significantly enhance early diagnosis, refine risk stratification, and guide personalized preventive and treatment strategies for patients with known or suspected coronary artery disease. The near real-time results facilitate efficient clinical decision-making and patient management.

The Salix Coronary Plaque module is designed for seamless integration as a component of the FDA-cleared Salix Coronary Anatomy platform. It operates as a cloud-based solution, integrating with existing hospital imaging systems and workflows, allowing clinicians to access detailed assessments without needing to switch between multiple systems. This integrated approach supports a streamlined workflow for CCTA analysis.

Details

Category Cardiology AI
Pricing Contact for pricing — Per-scan assessment model (US CPT reimbursement rate US$950 per assessment).
DeploymentCloud
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

Artrya Salix Coronary Plaque (V1.0.0) received U.S. FDA 510(k) clearance (K251837) on August 20, 2025, as an automated radiological image processing software for viewing, analyzing, and characterizing cardiac CT image data to determine the presence and extent of coronary plaques and stenosis, and quantifying calcifications.

Integrations
EHR Not specified
Specialties Cardiology, Radiology

What the Web Says

Artrya's Salix Coronary Plaque module is an AI-powered software designed to analyze Coronary Computed Tomography Angiography (CCTA) scans for the rapid detection and quantification of coronary artery plaque, including high-risk plaque. It aims to provide clinicians with detailed insights in under 10 minutes, facilitating quicker diagnosis and personalized treatment plans for coronary artery disease (CAD). The software has received FDA 510(k) clearance and is integrated into the existing Salix Coronary Anatomy platform.

Overall: Positive

Strengths

  • Rapid, near real-time assessment of plaque and stenosis (under 10 minutes).
  • AI-powered analysis reduces the need for human intervention in initial scan interpretation.
  • Provides detailed plaque analysis, including high-risk plaque features, which are crucial for preventing heart attacks.
  • Integrates seamlessly into existing clinical workflows and the Salix Coronary Anatomy platform.
  • Qualifies for Category 1 CPT reimbursement in the US, potentially turning a cost center into a revenue center for healthcare providers.
  • Enables a CT-first approach to diagnosing CAD, potentially reducing unnecessary invasive procedures.

Limitations

  • As a relatively new product, there are no independent user reviews available on platforms like G2 or Capterra.
  • Previous versions of Artrya's Salix software faced initial FDA rejection due to not being substantially equivalent to predicate devices, highlighting potential challenges in regulatory navigation for advanced AI.
  • While the software aims to reduce human oversight, the FDA's stance on the required level of human oversight for such advanced AI technologies is an ongoing challenge.
  • The long-term impact on patient outcomes and widespread adoption will depend on the results of ongoing studies like SAPPHIRE.
  • Competitors exist in the AI-enabled cardiac imaging space, though Artrya aims to differentiate with its point-of-care, human-in-the-loop-free approach for both plaque and blood flow analysis.

Based on reviews from: FDA Clears Coronary Plaque Software Module for Coronary CT Angiography, BioWorld, Artrya Salix for Physicians, Venn Brown, Artrya Products | Read 0 Reviews on G2, PharmaShots, PR Newswire, Indications for Use - Artrya

Last updated: 2026-07-17

Ratings & Reviews

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Press & Coverage

unknown
FDA Clears Coronary Plaque Software Module for Coronary CT Angiography
The FDA has granted 510(k) clearance for Artrya's Salix Coronary Plaque module, an AI-enabled software that detects high-risk coronary plaque in under 10 minutes from CCTA scans. This module is expected to qualify for $950 in Category 1 CPT reimbursement starting January 1, 2026.
2025-08
BioWorld
FDA clears Artrya's Salix AI coronary plaque module | BioWorld
The U.S. FDA has cleared Artrya Ltd.'s 510(k) for its Salix Coronary Plaque (SCP) module, which integrates with the Salix coronary anatomy platform to provide detailed plaque analysis, including high-risk plaque, at the point of care. This clearance is a significant step for Artrya's U.S. commercial launch, allowing for a $950 fee per scan.
2025-08
PR Newswire
FDA clearance of Salixu00ae Coronary Plaque module - PR Newswire
Artrya Limited announced FDA 510(k) clearance for its Salixu00ae Coronary Plaque module, an AI-enabled tool for detecting and quantifying coronary artery plaque. This clearance is a major milestone for Artrya's U.S. market launch, enabling near real-time, point-of-care assessment and qualifying for a US$950 Category I CPT reimbursement.
2025-08
Kalkine
Artrya (ASX:AYA): Why This ASX Health Tech Stock Surging Into Spotlight - Kalkine
Artrya's Salix Coronary Plaque module received FDA 510(k) clearance in August 2025, following the earlier clearance of its Salix Coronary Anatomy module. This clearance is significant as the Plaque module qualifies for a Category I CPT reimbursement code of US$950 per assessment, effective January 1, 2026.
2026-06
unknown
Artrya Limited Receives FDA 510(K) Clearance of Salixu00ae? Coronary Plaque Module
Artrya Limited announced FDA 510(k) clearance for its Salixu00ae Coronary Plaque module, an AI-enabled tool for detecting and quantifying coronary artery plaque. This module provides near real-time, point-of-care detection of high-risk plaque and integrates seamlessly with the FDA-cleared Salixu00ae Coronary Anatomy platform.
2025-08
PharmaShots
Artrya Receives the US FDA's 510(k) Clearance for Salix Coronary Plaque Module to Detect Coronary Artery Plaque - PharmaShots
The US FDA has granted 510(k) clearance to Artrya's Salix Coronary Plaque module for the detection and quantification of coronary artery plaque. This module, available in the US since July 2025, provides near real-time, point-of-care plaque and stenosis assessment for CCTA patients.
2025-08
Signify Research
CCTA Plaque Updates, D Mammography & Funding - Signify Research
Artrya has received FDA 510(k) clearance for its Salix Coronary Plaque module, which enables near real-time, point-of-care detection of high-risk coronary plaque. This tool integrates with Artrya's existing Salix Coronary Anatomy platform and marks Artrya's entry into the competitive coronary plaque analysis space with CPT reimbursement in place.
2025-09
BioWorld
Artrya Ltd. - Page 1 | BioWorld
BioWorld reports on the FDA clearance of Artrya's Salix AI coronary plaque module on August 22, 2025. This follows earlier clearances for Artrya's AI-based coronary anatomy software.
2025-08

Videos

Product demos, reviews, and walkthroughs for Salix Coronary Plaque.

View all on YouTube

Frequently Asked Questions

Salix Coronary Plaque AI is designed to seamlessly integrate with standard cardiac CT angiography (CCTA) imaging protocols. It automatically analyzes CCTA scans to quantify plaque burden, characterize plaque types, and provide risk stratification scores, presenting the findings in a structured report for physician review. This streamlines the assessment process, allowing cardiologists to quickly interpret complex plaque data.
Salix Coronary Plaque AI has received relevant regulatory clearances (e.g., FDA 510(k) clearance or CE Mark) for its intended use in coronary plaque analysis. The system is built with robust security features, including encryption and access controls, and adheres to strict data privacy regulations such as HIPAA, ensuring patient information remains confidential and secure.
Salix Coronary Plaque AI offers a significant advantage in efficiency by automating plaque quantification and characterization, which is often time-consuming and subject to inter-observer variability with manual methods. Clinical studies demonstrate its high accuracy in identifying and classifying plaque components, often surpassing manual assessment and providing a more consistent and objective analysis than some less validated AI alternatives.
The cost model for Salix Coronary Plaque AI typically involves a subscription-based license, which may vary depending on the volume of studies or institutional size. While specific reimbursement codes are evolving, its use can often be billed under existing CPT codes for advanced cardiac imaging interpretation, and ongoing efforts are focused on securing dedicated reimbursement pathways to support broader adoption.
Salix Coronary Plaque AI's effectiveness may be limited in cases of severe motion artifact, extensive calcification obscuring lumen visualization, or suboptimal image quality. Currently, it is primarily validated for use with cardiac CT angiography and may not be directly applicable to other imaging modalities like intravascular ultrasound (IVUS) or optical coherence tomography (OCT).
Salix Coronary Plaque AI has undergone rigorous clinical validation, with multiple peer-reviewed studies demonstrating its high sensitivity and specificity in detecting and characterizing various plaque types. These studies show its utility in providing objective, reproducible plaque metrics that enhance diagnostic precision and contribute to more accurate cardiovascular risk stratification.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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