Royal Philips is developing augmented-reality surgical navigation technology for use in image-guided open and minimally invasive spine procedures.
The technology employs high-res optical cameras mounted on a flat panel x-ray detector to image the surface of the patient. This view, plus an internal 3D view acquired by x-ray, construct a 3D augmented-reality view of the patient's external and internal anatomy. This real-time 3D view of the spine in relation to the incision sites is intended to support procedure planning, navigation and implant accuracy.
Under a joint clinical research program, hybrid ORs with this new capability will be installed in a network of ten clinical collaborators. Pre-clinical studies have demonstrated that the technology was significantly better in terms of overall accuracy vs. pedicle screw placement without the aid of Philips' technology (85% vs 64%).
7D Surgical, a Canada-based company, has received FDA 510(k) clearance in December 2016 for its Envision 3D Image Guidance System that uses 3D surfacing technology to achieve patient digitization, but does not employ the use of x-ray or intraoperative CT. Updated 1/23/17: 7D affirmed regulatory clearance in the U.S. and Canada, and is commencing execution of its North American commercialization strategy.