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September 28, 2010
FDA Clears Simbionix Rehearsal Studio Software
September 29, 2010—Simbionix Ltd. (Cleveland, OH) announced the receipt of US Food and Drug Administration clearance for the Procedure Rehearsal Studio software. The product is intended for use as a software interface and image segmentation system for the transfer of imaging data from a medical scanner such as a computed tomographic scanner to an output file. It is also intended as preoperative software for simulating and evaluating surgical treatment options. The company's three-dimensional segmentation model can be exported to the Simbionix Angio Mentor simulator practice environment. The results are an advanced method of creating an ever-expanding library of modules for training and postoperative debriefing.
“We have been using the Procedure Rehearsal Studio in our research and educational programs, and it has lived up to our fullest expectations,” commented Karl A. Illig, MD. “We began to practice using our carotid stents on the simulator before performing them in the operating room in 2008 and have been very impressed by its ability to improve our subsequent procedures. In my opinion, this is clearly the next step for medical simulation, where simulators will be used to plan procedures.”
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