FDA Radiology AI Devices

The VeriSight Intracardiac Echocardiography Catheters (VSICE2D and VSICE3D) are disposable devices used during cardiac procedures to provide real-time ultrasound imaging inside the heart and nearby vessels. They help clinicians visualize cardiac anatomy and physiology in both adult and pediatric patients for guidance during interventions, improving the accuracy and safety of heart treatments.

The VERAFEYE System by Luma Vision Limited is an advanced ultrasound imaging tool designed for real-time visualization inside the heart and great vessels during cardiac procedures. It includes a sterile catheter and an imaging console that creates 2D and 3D ultrasound images to help clinicians see cardiac anatomy and physiology, guiding interventions safely and accurately.