Wednesday, September 3, 2025

ImmersiveTouch Wins FDA Clearance for Breakthrough Augmented Reality Surgical System

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ImmersiveTouch Inc., a leading digital surgery company, announced that its groundbreaking augmented reality (AR) technology platform, ImmersiveAR, has received 510(k) clearance for clinical use in the operating room by the U.S. Food and Drug Administration (FDA). The Chicago-based company will commence immediate commercialization of the platform in the United States.

ImmersiveAR is a natural extension of ImmersiveTouch’s AI-powered suite of virtual surgical planning products and services, which are already significantly improving CMF surgeries by reducing the traditional pre-operative planning workflow from seven days to just minutes. Surgeons can simulate surgical changes to bones and plan the final aesthetic result, tailoring the procedure to the patient’s unique anatomy, thereby minimizing errors and complications. ImmersiveTouch technology is an accretive solution for hospitals to generate additional reimbursement from payors and lower their healthcare costs.

Dr. David Hirsch, MD, DDS, Senior Vice President of Dental Medicine at Northwell Health, shared, “This virtual reality and augmented reality imaging provides remarkably detailed images of a patient’s anatomy, helping us foresee complications and reduce both planning and surgical time, resulting in a safer patient experience with fewer complications.”

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“ImmersiveAR brings a new frontier in intraoperative 3D visualization,” said Jay Banerjee, CEO of ImmersiveTouch. “The surgical field has long relied on traditional two-dimensional imaging technology to navigate complex patient anatomy. Our platform introduces advanced holographic visualization to transform how surgeons plan and perform procedures.”

ImmersiveAR allows surgeons to visualize and interact with 3D virtual surgical plans created by ImmersiveTouch or other virtual surgical planning providers, overlaid in an operating room environment for a fully integrated workflow from surgical planning to intraoperative 3D visualization. Surgeons can double-check their planned movements and reduce the need for intraoperative trial and error. The platform is designed for use in several surgical procedures.

This announcement follows significant company momentum, including strategic partnerships and a growing presence in leading hospitals. ImmersiveTouch has served over 4,000 patients, demonstrating its impact on the healthcare sector.

Source: Businesswire

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