ImmersiveTouch Inc., a prominent digital surgery company, announced that its augmented reality (AR) platform, ImmersiveAR, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for clinical use in the operating room. This Chicago-based company is set to commercialize the platform immediately in the United States.
ImmersiveAR builds on ImmersiveTouch’s existing suite of AI-powered virtual surgical planning products and services, which have notably enhanced CMF (craniomaxillofacial) surgeries by drastically reducing pre-operative planning time from seven days to mere minutes. The platform allows surgeons to simulate bone alterations and plan the final aesthetic outcomes tailored to each patient's anatomy, aiming to minimize errors and complications. This technology also helps hospitals increase reimbursements from payors and reduce healthcare costs.
Dr. David Hirsch of Northwell Health praised the detailed imaging provided by the platform, noting its ability to foresee complications and reduce both planning and surgical time, thus enhancing patient safety. CEO Jay Banerjee highlighted that ImmersiveAR brings a new dimension to intraoperative 3D visualization, replacing traditional two-dimensional imaging with advanced holographic visualization for improved surgical planning and execution.
The ImmersiveAR platform enables surgeons to interact with 3D virtual surgical plans within the operating room, ensuring a seamless workflow from planning to intraoperative visualization. This integration helps surgeons verify their planned movements, reducing the necessity for intraoperative trial and error. The platform is designed for a range of surgical procedures.
This FDA clearance marks a significant milestone for ImmersiveTouch, which has established strategic partnerships and expanded its presence in leading hospitals. The company has served over 4,000 patients, underscoring its growing influence in the healthcare sector.
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