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Xironetic Receives FDA Clearance for Augmented Reality Surgical Software

Xironetic , an early-stage healthcare technology company, announced its IntraOpVSP augmented reality (AR) visualization software for complex surgeries has received clearance from the U.S. Food and Drug Administration (FDA).

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“Our software is a huge step forward for surgeons and their patients, and the FDA’s clearance is another important milestone in getting it into operating rooms everywhere.”

IntraOpVSP displays patient CT and MRI as three-dimensional holograms in AR headsets, helping surgeons visualize surgical plans, anatomical targets, and cutting guides alongside or overlayed on the patient. The software can be used during surgery and pre-operative planning and includes hand tracking and voice recognition features.

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Current and planned use cases for IntraOpVSP are expected to align to the needs of physicians across general, craniofacial and maxillofacial, neuro, orthopedic, plastic, thoracic and vascular surgery disciplines.

“IntraOpVSP is an extension to virtual surgical planning tools used today, bringing the insights of 3D visualization of CT and MRI data into the operating room to support improved surgical outcomes,” said Christian El-Amm, MD, Xironetic founder, and chief pediatric surgeon at Oklahoma Children’s Hospital. “Our software is a huge step forward for surgeons and their patients, and the FDA’s clearance is another important milestone in getting it into operating rooms everywhere.”

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