In just the last few years, augmented reality has become an increasingly viable tool for surgeons seeking real-time guidance throughout finicky procedures. The FDA has cleared a handful of AR-based technologies that add virtual overlays to a surgeon’s view, highlighting target areas and providing helpful calculations and other analytics on the side.
The latest to join that select group is OnPoint Surgical’s namesake AR system, which is specifically designed for use in spinal procedures.
The company announced the OnPoint system’s FDA 510(k) clearance Monday with CEO Philipp Lang noting in the release that it’ll now be available for use in clinical settings across the U.S.
OnPoint’s AR technology is loaded into a head-mounted display. While wearing the headset during a spinal procedure, surgeons can see through the display to watch what they’re doing, while also viewing digital overlays to guide them through the procedure.
For example, during pedicle screw placement, the screen will display a series of virtual lines over the patient’s spine to show ideal paths for the screws’ placement. Then, as the implants are inserted along those pathways, the headset’s display will show a virtual screw and screwdriver, with which the surgeon can align their actual tools for the most accurate implant placement.
The OnPoint system is meant to be used with implants from all major manufacturers, according to its maker, and doesn’t require surgeons to change anything about their current approaches to or techniques in spinal procedures.
According to OnPoint, surgeons who have used the technology on an experimental basis have been “highly enthusiastic” about it.
“Having used the OnPoint AR Spine System on several occasions during its development, I am deeply impressed by its unique accuracy, easy-to-use interface and the clarity of the information presented,” Michael Groff, M.D., vice chair of neurosurgery and director of spinal neurosurgery at Brigham and Women’s Hospital, said in the announcement.
“I believe that the benefit of this system will be in improving outcomes after surgery, increasing the safety of the surgery, the speed of the surgery and our confidence that all of our implants are in an optimal position for every patient,” he continued.
Additionally, the company claimed in its announcement that its technology far outstrips other AR-based surgical guidance systems.
Per OnPoint, its head-mounted display is up to 10 times lighter than other AR headsets and also boasts resolutions two to four times higher than its competitors in the spinal surgery space. Cadaver studies of the technology—the results of which are set to be presented at the 2023 Congress of Neurological Surgeons this week—reportedly showed that its use resulted in accuracy “exceeding that of all major existing navigation, robotic and augmented reality systems” two to five times over.