Medical Device Network

ImmersiveTouch bags FDA clearance for AR surgical system

Moving into the operating room for the first time, the company’s set of augmented reality planning tools now allows for real-time surgical assistance.

Virtual surgery firm, ImmersiveTouch has obtained US Food and Drug Administration (FDA) clearance for its augmented reality (AR) surgical system designed to assist in Craniomaxillofacial surgeries and other procedures.

Released as an extension to the company’s suite of artificial intelligence (AI) driven software that is designed to allow surgeons to directly interact with their surgical and anatomic plans in real-time, and map plans onto a patient’s specific anatomy.

The aim of the AR system is to reduce the operational workflow of the procedure by making patient information available as part of the AR device’s display with the goal of reducing worktime and complications.

Jay Banerjee, CEO of ImmersiveTouch, said: “ImmersiveAR brings a new frontier in intraoperative 3D visualisation. 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.”

This marks the first time that the company has moved from purely planning surgeries to gaining approval for clinical use in the operating room marking a step forward for the Chicago-based company. The devices head up display is viewed through a proprietary headset, with the company announcing that it plans to begin full commercialisation of the device immediately,

GlobalData’s Medical Device Intelligence Centre found that the overall global market for AR was estimated at a value of $7bn in 2020, with that figure expected to grow to $152bn by 2030, growing at a compound annual growth rate (CAGR) of 36%.

David Hirsch, senior vice president of dental surgery at US non-profit Northwell Health, added: “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.”

Elsewhere in the field of Augmented Reality-based devices, UK-based Fresenius Medical Care has introduced its own augmented reality application designed to train intensive care unit (ICU) nursing staff. At the same time, Cleveland-based company MediView XR unveiled results of a trial studying its XR90 surgical visualisation and navigation system.