FDA approval for Canadian VR tool for surgeons
December 1, 2021
VANCOUVER – PrecisionOS® has received a 510(k) clearance from the 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 (pictured), CEO of PrecisionOS. “Our new InVisionOS software, which took four years to develop, allows surgeons to visualize patient specific needs and better plan for surgery.”
As an orthopedic surgeon, Goel sees immersive VR as a critical step to improving patient care.
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.
PrecisionOS was founded in partnership with clinical orthopedic surgeon educators and an expert group of XR (virtual reality, augmented reality and mixed reality) developers to create simulation training for practicing surgeons, residents and surgical device representatives. Participants using PrecisionOS modules engage in a realistic operating environment, alone or in collaboration with other trainees anywhere in the world, test their knowledge and desire to try alternate approaches, receive instructive feedback and repeat procedures until achieving proficiency. With InVisionOS, a patient specific planning tool, the company is expanding into the provision of next generation products for preoperative surgery, simulation training and education. PrecisionOS is based in Vancouver, with collaborative affiliations with more than 40 major medical institutions in the U.S. and Canada. The company’s software is being used in more than 40 countries and 600 cities globally. For more information please visit www.precisionostech.com.