CAS-One IR
Cascination AGCAS-One IR is a system that assists doctors in planning and carrying out CT-guided needle procedures (like biopsies or ablations). It provides advanced navigation and verification tools—including AI-based image segmentation—to enhance accuracy and safety during interventions.
Intended Use
CAS-One IR is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of one or more instruments, as well as in verification of instrument position and performance during Computed Tomography (CT) guided procedures. CAS-One IR is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures. CAS-One IR is intended to be used for patients older than 18 years and eligible for CT-guided percutaneous interventions.
Technology
CAS-One IR consists of software that facilitates planning, navigation, and verification for CT-guided interventions. It provides AI-based segmentation for multiple abdominal organs and lesions, aids trajectory planning, and coordinates instrument alignment using optical tracking hardware and specialized accessories for patient immobilization and needle guidance.
Performance
Software verification and validation, segmentation algorithm performance (Dice coefficients on clinical data), hardware testing (including navigation accuracy, electrical safety to IEC 60601-1, EMC, and usability engineering). The system demonstrated high segmentation accuracy across all evaluated structures and non-inferior navigation accuracy compared to the predicate. No clinical studies were required.
Predicate Devices
No predicate devices specified
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