Hi-D Imaging 4TAVR
Hi-D Imaging AGHi-D Imaging 4TAVR is an AI-powered cloud-based software that helps healthcare professionals assess detailed cardiac CT images. It automatically segments the heart and vessels, performs 3D reconstructions, detects key anatomical landmarks, measures relevant parameters for TAVR procedures, and generates comprehensive reports. This supports clinicians in planning interventions efficiently and accurately.
Intended Use
Hi-D Imaging 4TAVR is a software as a medical device (SaMD) intended to support trained healthcare professionals with cardiovascular anatomy assessment and visualization, including pre-operational planning and sizing for transcatheter aortic valve replacement (TAVR).
Technology
The device uses AI deep learning models and computer vision methods to automatically segment CT-based cardiac anatomy, perform 3D reconstruction and visualization, detect anatomical landmarks and centerlines, and generate automated reports for TAVR planning.
Performance
The device was verified and validated per FDA guidance through software testing at unit, integration, and system levels, reproducibility testing on 100 cases showing >99.99% agreement, and usability studies with 15 users demonstrating zero use errors. Clinical validation was conducted on 929 CT scans showing >90% accuracy for annulus parameters and >85% for other TAVR parameters compared to expert manual measurements.
Predicate Devices
No predicate devices specified
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