ImmersiveTouch Secures FDA Clearance for Augmented Reality Surgical System

ImmersiveTouch, a virtual surgery firm, has secured clearance from the U.S. Food and Drug Administration (FDA) for its augmented reality (AR) surgical system, which is designed to assist in craniomaxillofacial surgeries and other procedures.

This new system enhances the company’s suite of artificial intelligence (AI)-powered software, allowing surgeons to engage with their surgical and anatomical plans in real time and align these plans with a patient’s unique anatomy.

The AR system’s goal is to optimize the surgical workflow by presenting patient information directly on the AR device, thereby reducing operational time and minimizing complications.

Jay Banerjee, CEO of ImmersiveTouch, remarked, “ImmersiveAR opens a new frontier in intraoperative 3D visualization. The surgical field has traditionally relied on two-dimensional imaging technology to navigate complex anatomical structures. Our platform introduces advanced holographic visualization that will change how surgeons plan and perform their procedures.”

This approval marks the first time the company has shifted from planning surgeries to gaining clinical use approval for operating rooms, indicating a significant milestone for the Chicago-based organization. The device features a head-up display that is viewed through a proprietary headset, and the company plans to begin full commercialization of the device immediately. According to GlobalData’s Medical Device Intelligence Centre, the global AR market was valued at $7 billion in 2020 and is projected to reach $152 billion by 2030, growing at a compound annual growth rate (CAGR) of 36%.

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