Simbionix of Cleveland, OH has received 510(k) approval from the FDA for the PROcedure Rehearsal Studio Software. The software creates patient-specific 3D anatomical models for use in analyzing and planning surgical procedures. The 3D model created by the PROcedure Rehearsal Studio Software can also be exported to the Simbionix ANGIO Mentor Simulator practice environment, allowing the user to rehearse difficult procedures.
Press release: Simbionix Receives FDA Clearance to Take Medical Simulation Technology One Step Further into Clinical Settings…
Product page: PROcedure Rehearsal Studio…