ADAS 3D
Adas3D Medical S.LADAS 3D is an AI-powered software tool that processes cardiac MRI and CT images to support visualization, quantification, and analysis of heart structures and myocardial fibrosis in patients with cardiovascular disease. It aids medical professionals in making informed decisions for cardiac care by providing detailed 3D imaging data, especially for pre-planning and during electrophysiology procedures.
Intended Use
ADAS 3D supports visualization and analysis of MR and CT images of the heart for patients with cardiovascular disease; used for calculation, quantification, and visualization of cardiac images for pre-planning and during electrophysiology procedures by qualified medical professionals.
Technology
ADAS 3D processes DICOM Heart MR, CT, and MRA images using machine learning for semi-automatic segmentation of cardiac structures (LV, LA, aorta, coronary arteries) and quantification of myocardial fibrosis and wall thickness; it exports results in standard file formats for catheter navigation systems.
Performance
Machine learning features were trained and tested on diverse, anonymized DICOM datasets acquired from multiple countries and scanner types; performance metrics show that ADAS 3D meets or exceeds acceptance criteria for segmentation and quantification accuracy, demonstrating safety and effectiveness comparable to its predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/22/2024
5 months - 2
FDA Approval
9/9/2024
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