FDA Authorizes PrecisionOS to Market VR Surgical Planning Tool

November 30, 2021 Press Release

Software Provides 3D Reconstruction of Patient CT Scans Via Oculus Quest 2

VANCOUVER, British Columbia—November 30, 2021—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.

About PrecisionOS

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 training for orthopedic surgeons. The company’s immersive simulations are scientifically validated, peer-reviewed and published in leading medical research journals. Participants 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.

PrecisionOS is based in Vancouver, BC, 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.

Media Contact:

Elaine Murphy
818.613.1951
emurphypr@outlook.com

About Peter Coffaro 487 Articles

A growth-driven and strategic executive, Peter Coffaro commands more than 25 years of progressive management success within the medical device industry. Recognized by the World Journal of Orthopedics, Exponential Healthtech, and MedReps.com as one of the top medical sales influencers in the industry; he has 10 years of combined sales management experience and has held positions as a Director, General Manager, Distributor, and Vice President. Peter has worked for some of the top orthopedic companies in the world - Zimmer, DePuy, and Stryker. He is also the founder of OrthoFeed: a popular blog that covers digital orthopedic news and emerging medical technologies. Peter is a three-time Hall of Fame award winner at Johnson and Johnson and has an extensive background in organizational development, business development, sales management, digital marketing, and professional education. Peter holds a B.S. degree in Biology and Chemistry from Northern Illinois University.