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FDA Authorizes PrecisionOS to Market VR Surgical Planning Tool


PrecisionOS has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market InVisionOS a patient specific planning tool using virtual reality (VR). The patented software, to be available in early 2022, lets surgeons use an Oculus Quest 2 device to do preoperative planning.

InVisionOS is a next generation patient specific planning tool. Currently surgeons view a simulated 3D image of the patient on a computer screen and then carry that mental model to the operating room. InVisionOS software automatically converts the patient’s computed tomography (CT) scan from any PACS system into a 3D reconstruction within seconds. Surgeons can then use the Oculus Quest 2 to view, manipulate and isolate relevant anatomical areas prior to performing the actual surgical procedure.

“We focus on developing products that improve the confidence, competency and proficiency of surgeons, ultimately benefiting patient outcomes,” says Danny Goel, M.D., CEO, PrecisionOS. “Our new InVisionOS software, which took four years to develop, allows surgeons to visualize patient specific needs and better plan for surgery.”

InVisionOS is a class-II medical device cleared under the FDA’s 510(k) premarket submission program, which required that the company demonstrate the safety and effectiveness of the device.

 

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