FDA approves Simbionix pre-op simulator

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The FDA has approved Simbionix’s Procedure Rehearsal Studio Software, which is intended for pre-operation simulation and for the transfer of medical data from CT or other scanners to output files.

Simbionix’s simulation software was used by the University of Rochester Medical Center in Rochester, N.Y., for pre-op research and education prior to implanting carotid stents in patients, according to Cleveland, Ohio-based Simbionix and Karl A. Illig, MD, professor of surgery and neurosurgery at the University of Rochester.

The company said its software can also be used as an interface and image segmentation system for transferring imaging data from scanners to output devices.