PrecisionOS Gains FDA 510(k) for InVisionOS Planning Tool with Virtual Reality

By Julie A. Vetalice

PrecisionOS Gains FDA 510(k) for InVisionOS Planning Tool with Virtual Reality

PrecisionOS received FDA 510(k) 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 perform preoperative planning.

InVisionOS is a next-generation 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 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.

Source: PrecisionOS

Product Labels: Surgical Planning

Tags: 510(k) Clearance, Regulatory