MPXA-2000

by Medipixel  · Based in South Korea → — AI-driven Solutions for Cardiovascular Interventions
Cardiology

Regulatory Status Disclosed

Overview

Medipixel is a global healthcare company dedicated to improving the quality of human life by applying advanced AI technology to healthcare. Their primary focus is on revolutionizing diagnostic and treatment protocols within the cardiovascular field, with an expanding interest in neurovascular care. The flagship product, MPXA-2000, is an AI-based software medical device designed for the comprehensive analysis of cardiovascular angiography images.

MPXA-2000 seamlessly integrates into the cath lab workflow, providing real-time, automated quantitative analysis of coronary artery stenotic lesions. Utilizing cutting-edge deep learning and computer vision algorithms, it performs vessel segmentation and calculates precise dimensions, offering measurements comparable to those obtained through intravascular ultrasound (IVUS). This tool supports cardiologists and radiologists in making informed clinical decisions, evaluating interventions, and assessing drug therapies for adult patients with coronary artery disease (CAD).

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automatic analysis of 2D angiography images
  • AI algorithm for quantifying coronary artery stenotic lesions
  • Provides measurements similar to intravascular ultrasound (IVUS)
  • Real-time analysis of cardiovascular condition
  • Supports clinicians in decision-making during PCI
  • Vessel segmentation and lesion analysis
  • Highly accurate quantitative analysis
  • Compatible with DICOM standard X-ray angiographic images from Philips Medical Systems, Siemens Healthineers, GE Healthcare

Use Cases

  • Supporting clinical decisions concerning coronary arteries
  • Evaluating intervention or drug therapy for coronary artery conditions
  • Quantitative analysis of cardiovascular images in cath labs
  • Assisting in stent sizing during PCI procedures

What Physicians Need to Know

Coronary Artery Assessment
MPXA-2000 is an AI-powered solution that analyzes coronary angiography images in real-time to identify constricted areas, quantify the extent and length of blockages, and provide objective numerical and visual data to complement physician judgment. It calculates the exact centerline, length, and diameter of the vessel, offering accurate region of interest (ROI) analysis results, including reference lines and stenosis percentage. The system also offers automated vessel contour segmentation and analysis of multiple ROIs. MPXA-2000 has been shown to guide procedures at a level comparable to Optical Coherence Tomography (OCT) by analyzing real-time procedural images non-invasively. It can detect multiple lesions and present the severity of stenosis in both the primary coronary artery and its branch vessels.
Real-Time Alert Capability
MPXA-2000 provides real-time analysis of coronary angiography images, delivering results within 1-2 seconds. This swift performance enables its use during cath lab procedures, supporting interventionalists with immediate data for decision-making. The system analyzes transferred images in the procedure room and outputs results in real time, assisting with PCI procedural assistance and stent sizing.
AHA/ACC Guideline Alignment
While not explicitly stated as AHA/ACC guideline alignment, Medipixel's MPXA-2000 has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and medical device certification from the Ministry of Food and Drug Safety (MFDS) in Korea. This regulatory approval indicates that the device meets established standards for safety and effectiveness.
Cardiac Monitoring Integration
MPXA-2000 integrates into the cath lab workflow, where DICOM contrast images are uploaded to the system in real time during cardiovascular imaging. It supports cardiologists and cath lab staff with PCI procedural assistance.
Physician Tip

MPXA-2000 offers real-time, AI-powered quantitative analysis of coronary angiography images, which can significantly reduce the limitations of visual estimation and inter-observer variability in the cath lab. The rapid analysis and automated features, such as vessel segmentation and lesion quantification, can enhance procedural efficiency and support faster, more objective treatment decisions during PCI. The ability to recommend optimal stent location, length, and diameter based on accurate ROI analysis can further aid in procedural planning. This tool has been shown to achieve comparable outcomes to OCT in cardiovascular procedures, offering a potentially simpler and faster workflow.

MPXA-2000 integrates into the cath lab workflow by processing DICOM contrast images in real-time during cardiovascular imaging. It supports various output formats for result reports, including Excel, PDF, and DICOM (scheduled support), enhancing usability in medical settings.

Details

Category Cardiology AI
Pricing Unknown
DeploymentStand-alone application; integrates seamlessly into cath lab workflow
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Cardiology

What the Web Says

MPXA-2000 by Medipixel is an AI-powered software designed for quantitative coronary angiography (QCA) that analyzes 2D angiography images to quantify coronary artery stenotic lesions. It aims to assist physicians in making clinical decisions during percutaneous coronary intervention (PCI) by providing automated, real-time quantitative information. Studies have shown it to have a moderate to strong correlation with intravascular ultrasound (IVUS) and to outperform visual estimation by cardiologists in lesion detection and quantification.

Overall: Positive

Strengths

  • Automated and real-time quantitative analysis of coronary angiography images.
  • Potential to support clinical decisions and improve patient outcomes.
  • Moderate to strong correlation with IVUS for reference vessel size and stenosis severity.
  • Superiority over visual estimation by cardiologists in lesion detection and quantification.
  • High sensitivity in detecting lesions in major vessels and side branches.
  • Potential to reduce healthcare personnel's time by offering consistent lesion identification and analysis.

Limitations

  • Moderate correlation for percent area stenosis and lesion length compared to IVUS.
  • Tendency to underestimate reference vessel area and mildly atherosclerotic lesions.
  • Geographic mismatch in proximal or distal lesion margins compared to IVUS.
  • Workflow convenience issues, such as steps for sign-in, image selection, and frame selection, may impede user experience.
  • Potential barriers include the need for training and associated costs.
  • System Usability Scale (SUS) score of 66.7 indicates marginal high acceptability.

Based on reviews from: jmir.org, researchgate.net, mdpi.com, medium.com, amegroups.org, bdmtglobal.com, healthaidb.com

Last updated: 2026-10-31

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Press & Coverage

medipixel.io
Medipixel XA received 510K clearance by U.S. FDA
Medipixel announced on March 27th that its AI cardiovascular disease diagnosis assistance solution 'Medipixel XA' (model name: MPXA-2000) received final 510K clearance from the U.S. FDA. This marks the first FDA approval for a South Korean company's AI product that performs automatic and real-time analysis of various vascular lesions.
2023-03
EurekAlert!
Revolutionizing cardiology: AI-based technology offers accurate analysis of cardiac disease
New research published in JMIR Cardio on June 12, 2023, highlights the potential of AI-based automated quantitative coronary angiography (AI-QCA) using Medipixel's MPXA-2000 for accurate analysis of heart disease. The study, led by Dr. In Tae Moon, compared AI-QCA to intravascular ultrasound (IVUS) and found it provided accurate measurements of coronary stenotic lesions.
2023-06
Journal of Medical Internet Research
Accuracy of Artificial Intelligence–Based Automated Quantitative Coronary Angiography Compared to Intravascular Ultrasound: Retrospective Cohort Study
A study published on April 26, 2023, in JMIR Cardio validated the performance of Medipixel's MPXA-2000 software for AI-based quantitative coronary angiography (AI-QCA) against intravascular ultrasound (IVUS). The retrospective cohort study found a moderate to strong correlation between AI-QCA and IVUS in analyzing coronary lesions with significant stenosis.
2023-04
medipixel.io
Medipixel Secures Top Position in World Medical Artificial Intelligence Competition
Medipixel announced on October 10, 2023, that it secured the top spot in the Cardiovascular Artificial Intelligence Algorithm Challenge (ARCADE) at the MICCAI conference. The competition focused on Stenosis Detection and Vascular Segmentation using x-ray angiography images, with Medipixel's MPXA-2000 being highlighted as real-time analysis software that identifies constricted areas and provides numerical data.
2023-10
medipixel.io
Medipixel Receives MFDS Certification for MPXA-2000
Medipixel announced on November 2, 2021, that its cardiovascular disease diagnostic support AI software, 'MPXA-2000,' received medical device certification from the Ministry of Food and Drug Safety (MFDS) for domestic sales in Korea. The MPXA-2000 is an upgraded version of MPXA-1000 and is capable of automatically analyzing coronary artery branch lesions in real-time.
2021-11
medipixel.io
Medipixel Signs Export Contract with Indian Medical Equipment Company Innvolution Healthcare
Medipixel announced an export contract worth 6 billion won ($4.5 million) with Indian medical equipment company Innvolution Healthcare. The agreement involves providing Medipixel's AI-based cardiovascular disease automatic analysis software, 'MPXA-2000,' for installation with Innvolution's coronary angiography imaging equipment over three years.
2023-09
healthcareaiops.com
FDA 510(k) K222036: MPXA-2000 by Medipixel, Inc., cleared 2023-03-22 under AI-associated product code QIH.
Medipixel, Inc.'s MPXA-2000 received FDA 510(k) clearance on March 22, 2023, under the AI-associated product code QIH. This information is part of a public record of AI/ML medical devices cleared by the FDA.
2023-03
MDPI
Generalizability of Artificial Intelligence-Based Quantitative Coronary Angiography in a European Population
A study published on February 19, 2026, in MDPI evaluated the generalizability of Medipixel's AI-QCA software (MPXA-2000 Version 1.1.0), trained on an Asian population, in a European dataset. The research aimed to assess the software's performance across different populations, highlighting the importance of external validation for AI-based medical devices.
2026-02

Videos

Product demos, reviews, and walkthroughs for MPXA-2000.

View all on YouTube

Frequently Asked Questions

MPXA-2000 is an AI-powered software developed by Medipixel for real-time analysis of cardiovascular angiography images. It identifies constricted areas, quantifies the extent and length of blockages, and provides numerical data to assist cardiologists in making clinical decisions and planning procedures like PCI.
MPXA-2000 has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and is also certified by the Korean Ministry of Food and Drug Safety (MFDS).
MPXA-2000 automatically analyzes 2D angiography images to quantify coronary artery stenotic lesions, providing measurements similar to intravascular ultrasound (IVUS) but in a less invasive manner. It also aims to overcome the limitations of manual quantitative coronary angiography (QCA) by offering automated, real-time analysis, reducing inter-observer variability, and enhancing the accuracy and efficiency of intervention planning.
While MPXA-2000 offers significant advancements, earlier versions had limitations in analyzing lesions at side branches and certain arterial segments in specific angiographic views. However, the MPXA-2000 version has incorporated improvements to address these issues, including expanded segmentation area and local refinement techniques.
Yes, the field of AI in cardiology is growing, with several companies offering solutions for cardiac diagnosis, monitoring, and patient care. Some examples include AI-powered tools from GE HealthCare, Koninklijke Philips N.V., Siemens Healthineers AG, and Cleerly, Inc., which focus on various aspects like echocardiographic imaging, cardiac MR planning, and plaque analysis.
In a cath lab, DICOM contrast images are uploaded to MPXA-2000 in real-time during cardiovascular imaging. The software then analyzes the images and outputs results in real-time, assisting cardiologists and cath lab staff with PCI procedural assistance and supporting clinical decisions regarding coronary vessel status.

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