Alphenix

Cardiology Interventional Radiology Vascular Surgery

Regulatory Status Disclosed

Overview

The Alphenix series, including models like INFX-8000V/B and INFX-8000V/S, is an interventional fluoroscopic X-ray system developed by Canon Medical Systems Corporation. It is designed to provide real-time X-ray imaging, primarily assisting clinicians during complex interventional procedures, particularly in cardiology. The Alphenix / Evolve Edition, for instance, integrates advanced Artificial Intelligence (AI) through its “αEvolve Technology” to enhance image quality, improve safety, and increase efficiency in diagnosis and treatment. Key AI functionalities include αEvolve Imaging, which utilizes deep learning for noise reduction and multi-frequency processing to deliver sharp and clear fluoroscopic images, often achieving a higher contrast-to-noise ratio than conventional methods. Another significant AI feature is the Dynamic Device Stabilizer (DDS), which employs deep learning to automatically detect, magnify, and stabilize balloon markers in real-time, aiding in precise stent visualization and assessment. For structural heart disease procedures, Echo Fusion leverages deep learning to automatically identify echocardiography probes and seamlessly fuse fluoroscopic and echo images. The Alphenix 4D CT configuration further extends these capabilities by combining the angiography system with a CT scanner, offering AI-driven imaging and workflow intelligence for comprehensive diagnosis, planning, treatment, and verification in a single suite. The system is indicated for diagnostic and angiographic procedures involving blood vessels in various parts of the body, including the heart, brain, abdomen, and lower extremities.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • u03b1Evolve Technology (AI-leveraged for diagnosis and treatment in interventional cardiology)
  • u03b1Evolve Imaging (Deep Learning-based noise reduction and multi-frequency processing for high-quality fluoroscopic images)
  • Dynamic Device Stabilizer (DDS) (Deep learning for automatic real-time detection, magnification, and stabilization of balloon markers for stent visualization)
  • Echo Fusion (Deep learning to automatically identify echocardiography probes and fuse fluoroscopic and echo images for structural heart disease procedures)
  • AI-driven imaging with workflow intelligence (integrated into Alphenix 4D CT)
  • Left Atrial (LA) Auto Segmentation Feature (automatic segmentation of CT or MR cardiac volume data for overlay on live fluoro image)
  • Real-Time Auto-Pixel Shift (automatically corrects misalignment during digital subtraction angiography and 2-D roadmapping)
  • Illuvis technology (noise reduction protocol for clearer images, especially in cardiac applications)

Use Cases

  • Interventional Cardiology procedures, including Percutaneous Coronary Intervention (PCI) and Structural Heart Disease (SHD) procedures
  • Diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities
  • Enhanced visualization and assessment during stent placement, device positioning, and expansion
  • Left atrial appendage (LAA) closure procedures
  • Comprehensive diagnosis, planning, treatment, and verification in Interventional Radiology (with Alphenix 4D CT)
  • Real-time volume navigation with 3D Roadmap (3DRM) and Multi-Modality Fusion (MMF)

What Physicians Need to Know

Echocardiography AI Features
The Alphenix / Evolve Edition includes 'Echo Fusion' which leverages deep learning to automatically identify the echocardiography probe and efficiently fuse fluoroscopic and echo images, aiding in structural heart disease procedures like left atrial appendage closure.
Cardiac CT/MRI Analysis
Alphenix offers a Left Atrial (LA) Auto Segmentation Feature, allowing automatic segmentation of CT or MR cardiac volume data for overlay on live fluoroscopic images. It also supports Multi-Modality Fusion (MMF) to superimpose 3D enhanced images from CT, MRI, or angiography systems with live fluoroscopy. Integration with Vital's Vitrea software provides advanced post-processing tools for CT Cardiac Analysis, CT Mitral Valve Analysis, and CT TAVR Planning.
Coronary Artery Assessment
The system features comprehensive coronary tools with automatic contour detection in both 2D and 3D, cross-section analysis, and stent enhancement. The Dynamic Device Stabilizer (DDS) uses deep learning to automatically detect and stabilize balloon markers in real-time for improved stent visualization during complex PCI procedures. u03b1Evolve Imaging utilizes deep learning-based noise reduction and multi-frequency processing for clear fluoroscopic imaging, enhancing the visibility of coronary arteries and devices. The Hi-Def detector technology provides up to 76-micron resolution for visualizing fine details in coronary vasculature.
Cardiac Monitoring Integration
Alphenix integrates with QMAPP, a compact hemodynamic monitoring system, allowing direct control of QMAPP functionalities, including 12-lead ECG, invasive blood pressure, and cardiac output measurements, from the Alphenix tablet.
AHA/ACC Guideline Alignment
The Alphenix / Evolve Edition is designed to enhance imaging while enabling reduced time and radiation dose during routine and complex percutaneous coronary intervention (PCI) and structural heart disease (SHD) procedures, aligning with guidelines for patient and staff safety. Its DoseRite tools, including Spot Fluoroscopy and a Dose Tracking System (DTS), help minimize radiation exposure.
Real-Time Alert Capability
The u03b1Evolve technology provides real-time assistance for diagnostic and therapeutic decisions without interrupting workflow. The Dose Tracking System (DTS) offers real-time information on radiation dose, enabling operators to adjust their approach to avoid exceeding dose thresholds. The Dynamic Device Stabilizer (DDS) provides real-time magnification and stabilization of devices.
Physician Tip

Leverage Alphenix's u03b1Evolve AI solutions, particularly Dynamic Device Stabilizer (DDS) and u03b1Evolve Imaging, for enhanced real-time visualization of stents and balloons during complex PCI, potentially reducing the need for digital acquisition and minimizing radiation dose. Utilize the Echo Fusion feature for improved guidance during structural heart disease procedures by seamlessly integrating echocardiography with fluoroscopy. Maximize the integration with QMAPP for comprehensive hemodynamic monitoring directly from the angiography suite, streamlining workflow and patient management. Explore the multi-modality fusion capabilities for pre-procedural planning and intra-procedural guidance using imported CT/MR data, especially for complex anatomies or LAA closure. The Hi-Def detector can be crucial for visualizing fine details in challenging cases.

Alphenix integrates with Canon Medical's Vital Vitrea advanced visualization software for comprehensive CT/MR cardiac analysis and planning. It also seamlessly integrates with the QMAPP hemodynamic monitoring system (a Fysicon B.V. product, a Canon group company) for real-time physiological data within the interventional suite. The system's Multi-Modality Fusion (MMF) allows for the overlay of 3D data from external CT, MRI, or angiographic systems. PIE Medical's 3D Quantitative Coronary Analysis (3D QCA) software is also available for integration, providing detailed coronary artery assessment.

Details

Category Cardiology AI, Radiology & Imaging AI, Surgical AI
Pricing Unknown
DeploymentHardware (Interventional X-ray system)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with αEvolve Imaging, is an interventional fluoroscopic X-ray system that received FDA approval on October 10, 2025. Its αEvolve Imaging chain, intended for adults, incorporates Artificial Intelligence Denoising (AID) to reduce noise in real-time fluoroscopic images and utilizes a Multi Frequency Processing (MFP) signal enhancement algorithm.

Integrations
EHR Not specified
Specialties Cardiology, Interventional Radiology, Vascular Surgery

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Press & Coverage

Applied Radiology
Canon Medical Receives FDA Clearance for Alphenix 4D CT with Aquilion ONE/INSIGHT Edition
Canon Medical announced FDA clearance for its Alphenix 4D CT with Aquilion ONE/INSIGHT Edition, a hybrid Angio-CT solution designed to streamline interventional radiology workflows. This system combines high-definition angiography with a fast CT scanner for in-room diagnosis, planning, treatment, and verification.
2025-11
Canon Medical Systems USA
Canon Medical Systems USA Receives FDA 510(k) Clearance for Alphenix / Evolve Edition with u03b1Evolve Imaging u2013 Debuted at TCT 2025
Canon Medical Systems USA received FDA 510(k) clearance for its Alphenix / Evolve Edition with u03b1Evolve Imaging, an interventional cardiology imaging system utilizing deep learning technology to enhance fluoroscopic imaging quality during PCI procedures. The system offers real-time support for diagnostic and therapeutic decisions.
2025-11
Canon Medical Systems
Canon announces global commercial launch of Alphenix 4D CT with Aquilion ONE / INSIGHT Edition for Interventional Procedures
Canon announced the global commercial launch of its Alphenix 4D CT with Aquilion ONE / INSIGHT Edition, following FDA clearance and a successful European launch. This hybrid Angio-CT solution aims to advance interventional therapy with enhanced clinical workflows, allowing diagnosis, planning, treatment, and verification in a single room.
2025-11
AuntMinnie
FDA approves Canon's hybrid interventional system
The FDA has approved Canon Medical Systems USA's Alphenix 4D CT with Aquilion One/Insight Edition, an interventional imaging system that combines angiography and CT capabilities. This integrated multimodal system is designed to eliminate patient transfers between departments for diagnosis, planning, treatment, and verification in interventional radiology.
2025-11
Surgical Robotics Technology
Canon Medical Launches Alphenix / Evolve Edition Angiography System
Canon Medical launched its Alphenix / Evolve Edition angiography system, which uses real-time deep learning technology to improve imaging and reduce procedure time and radiation dose during complex percutaneous coronary intervention (PCI) and structural heart disease procedures. This system aims to enhance safety for both clinicians and patients.
2023-08
Canon Medical Systems
Canon Medical announces release of Alphenix / Evolve Edition*u00b9, infusing real-time AI technology for Interventional Cardiology Suites
Canon Medical announced the commercial release of its Alphenix / Evolve Edition angiography system in Japan, Asian, African, and European markets. This system integrates real-time deep learning technology to enhance imaging quality and reduce radiation dose during interventional cardiology procedures, improving safety and efficiency.
2023-08
Canon Medical Systems
Alphenix Shipment Exceeds 1,000 u2013 More and More Alphenix Users Across the World
Canon Medical celebrated a milestone with over 1,000 Alphenix system shipments worldwide by September 2023. The Alphenix series has continuously evolved since its 2018 release, with the Alphenix / Evolve Edition, featuring AI technology, launched in August to further assist clinicians in interventional cardiology.
2023-09
Canon Medical Systems
Exploring Scientific and Clinical Functionalities of Alphenix 4D CT in UZ Brussels
UZ Brussels has integrated the Alphenix 4D CT from Canon into its radiology department, utilizing its combined CT and angiography capabilities in one room to improve patient care and clinical workflow. Recent studies highlight its use in assessing critical limb ischemia with low contrast agent volumes, benefiting diabetic and chronic kidney disease patients.
2021-08

Videos

Product demos, reviews, and walkthroughs for Alphenix.

View all on YouTube

Frequently Asked Questions

The Alphenix system, particularly with its u03b1Evolve Edition, leverages AI through deep learning to improve image quality, reduce noise, and enhance device visibility in real-time fluoroscopic imaging. This includes features like Dynamic Device Stabilizer (DDS) for automatic balloon marker detection and stabilization, and Echo Fusion for seamless integration of fluoroscopic and echo images, aiming to reduce radiation dose and improve procedural efficiency.
A primary limitation is that the AI technology in Alphenix, specifically u03b1Evolve Imaging, does not have a self-learning function; its algorithms are pre-trained during development and do not adapt or modify programs based on real-time clinical data at the user's site. Physicians should understand that the AI provides real-time assistance based on its initial training.
Canon Medical states that its AI technologies undergo rigorous testing in both development and clinical phases. While specific details on data privacy protocols for AI within Alphenix are not extensively detailed in the provided search results, medical device manufacturers are generally subject to regulations like HIPAA and GDPR, and AI governance is becoming a required pillar of enterprise compliance programs in healthcare.
Competitors offering interventional angiography systems with AI capabilities include Philips with its Azurion (e.g., ClarityIQ), Siemens Healthineers with ARTIS icono (utilizing AI technology for smart interventional experiences), GE HealthCare with Allia IGS (AI image enhancement), and Shimadzu with Trinias (AI-powered image clarity). These systems also focus on dose reduction and workflow enhancements.
The cost of an Alphenix system is influenced by its configuration (e.g., Alphenix Core+, Sky+, Biplane, or 4D CT), detector size, and the inclusion of advanced features like the Hi-Def Detector and u03b1Evolve AI technologies. While specific pricing for AI features isn't separately listed, systems with integrated AI and advanced capabilities generally represent a premium investment compared to basic, non-AI enabled angiography systems, reflecting the enhanced imaging and workflow benefits.
Alphenix's AI contributes to patient safety by enabling significant radiation dose reduction, as u03b1Evolve Imaging can reduce the reliance on digital acquisition and achieve high-quality images with lower dose. For workflow efficiency, features like Dynamic Device Stabilizer and Echo Fusion provide real-time assistance without interrupting procedural flow, streamlining complex procedures and aiding clinical decision-making.
The AI in Alphenix systems, specifically u03b1Evolve Imaging, utilizes pre-trained deep learning algorithms and does not possess a self-learning function that allows it to modify its programs or adapt based on local clinical data after implementation. The training of the AI algorithm is conducted during the development phase by Canon Medical.

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