ADAS 3D
Adas3D Medical S.L.ADAS 3D is a software tool that uses AI to analyze and visualize MRI and CT images of the heart to help medical professionals assess cardiovascular disease, including myocardial scarring. It supports detailed 3D cardiac imaging analysis and aids in planning electrophysiology procedures, enhancing clinicians' ability to interpret complex heart structures.
Intended Use
ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart on individual patients with cardiovascular disease, specifically myocardial scar produced by ischemic or non-ischemic heart disease. Intended for qualified medical professionals for pre-planning and during electrophysiology procedures to support clinical decision making.
Technology
ADAS 3D is stand-alone software that processes cardiovascular MR and CTA images in DICOM format. It uses machine learning to automatically identify and segment cardiac structures including the left ventricle, left atrium, coronary arteries, and other anatomical features. It exports data for use in catheter navigation and supports advanced 3D visualization including stereoscopic display.
Performance
Performance testing included software verification, validation, cybersecurity assessments, and analytical validation of image processing and machine learning features. The machine learning models were trained and tested on diverse anonymized MR and CT data sets from multiple manufacturers and hospitals. Testing demonstrated performance in line with the predicate device, meeting acceptance criteria for cardiac structure segmentation and analysis.
Predicate Devices
No predicate devices specified
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