FDA OKs First VR Surgical Planning Service for Oral, Maxillofacial Surgery

ImmersiveTouch Inc., announced the Food and Drug Administration (FDA) has provided 510(k) clearance for its ImmersiveView Surgical Plan (IVSP) digital surgery platform. IVSP saves surgeons time by providing an intuitive software suite to plan cases independently with help from biomedical engineers, cutting surgical planning time by as much as 75 percent. IVSP is the only service that provides patient-specific 3D models with every case to enhance clinical performance.
 
“This technology will not only help the surgeon prepare, predict and plan for any potential complication but will also improve patient outcomes by reducing complications, shortening operative time and providing more accurate personalized care. All this is achieved by utilizing virtual reality and 3D printing,” said Joseph Krajekian, M.D., Oral & Maxillofacial Surgeon at the Cleveland Clinic. “It is personalized surgery at its best and should be the standard of care. I have found ImmersiveTouch biomedical engineers to be the most creative, solution oriented, accurate, knowledgeable and reliable in the industry.”
 
Currently, 3D models and surgical planning services are cost-prohibitive and time consuming for hospitals and surgeons. With IVSP, surgeons now have the opportunity to plan for surgeries on their own schedules with quicker turnaround times than existing virtual surgical planning services. IVSP allows surgeons to visualize and plan for surgery to a level never before imagined using immersive medical imaging and surgical simulation. It gives the surgeon, via an Oculus headset and hand controllers, the ability to study patient specific anatomy, tumor margins, vital structures and deformative analysis.
 
“Once we put the Immersive headset on, it allows us to cross the 2D glass barrier into the other side, into a different universe where we can actually interact with the anatomy and simulate surgery,” said Pravin Patel, M.D., Chief of Pediatric Plastic and Craniofacial Surgery at University of Illinois Health & Medical Science Center.
 
IVSP is now available for sale in the United States and includes planning services for Orthognathic, Reconstruction and TMJ cases. VR simulations, 3D anatomical models, surgical splints and surgical guides are designed and 3D printed following the online planning session between the surgeon and ImmersiveTouch biomedical engineers.
 
“Our FDA cleared IVSP platform was made possible through close collaboration with surgeons. Our mission is to give surgeons more control by creating technology that caters to their needs and fits within their workflow,” said Pat Banerjee, founder and CEO of ImmersiveTouch.