MPXA-2000
Medipixel, Inc.MPXA-2000 is a software tool intended for cardiologists and radiologists to automatically analyze X-ray angiographic images of the coronary arteries. It uses deep learning and computer vision algorithms to segment blood vessels, classify vessel types, quantify vessel dimensions, and support clinical decisions related to coronary artery disease. The software provides validated, reproducible quantitative results to aid in diagnosis and treatment evaluation, with results available for review and export.
Intended Use
MPXA-2000 is software intended to perform calculations in X-ray angiographic images of the coronary arteries, providing vessel contour detection for review and manual editing by clinicians. It supports clinical decisions for coronary artery conditions and evaluation of interventions or drug therapy in adult patients.
Technology
MPXA-2000 is a stand-alone cardiovascular image analysis software using deep-learning based classification and segmentation of vessels combined with computer vision for measurements. It supports image uploading, frame selection, vessel segmentation and classification, ROI quantification, and result visualization/export. It processes DICOM X-ray angiographic images from various vendors and includes manual editing tools for contour correction.
Performance
Performance testing included extensive software verification and validation per IEC 62304 and FDA guidance. Standalone performance testing on 305 US coronary angiograms measured vessel segmentation (DSC 0.92), vessel classification (accuracy 0.9934), and ROI analysis, demonstrating reliable functionality consistent with predicate device performance. No clinical studies were required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/11/2022
8 months - 2
FDA Approval
3/22/2023
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