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510(k) Clearance Granted to OnPoint Surgical's Augmented Reality Spine System

Tuesday, September 12, 2023

OnPoint Surgical, a member of a group of privately held OnPoint companies known for its pioneering work in augmented reality (AR) technology and artificial intelligence (AI) applications across various medical fields, including spine, neurosurgery, orthopedics, and robotics, has received clearance from the US Food and Drug Administration (FDA) for its groundbreaking OnPoint Augmented Reality Spine System. This innovative system promises to redefine spinal procedures by seamlessly integrating virtual surgical guides and virtual implants into the surgeon's visual field through its proprietary see-through optical head-mounted display technology.

The medical community has responded with enthusiasm to the OnPoint AR Spine System during experimental use, highlighting its intuitive and user-friendly interface. Importantly, this open platform system is fully compatible with implants from major manufacturers, necessitating no alterations to established surgical techniques or protocols. Offering a cost-effective and highly precise alternative to existing robotic systems, the technology is not only suitable for implementation in hospitals but also for use in ambulatory surgery centers (ASCs), thanks to its compact design.

In comparison to existing AR systems for spinal procedures, the head-mounted display of the OnPoint AR Spine System is significantly lighter (4-10 times) and boasts a notably higher resolution (2-4 times). These advantages, coupled with the recent 510(k) clearance, clear the path for widespread adoption nationwide, promising improved surgical outcomes, enhanced safety during procedures, expedited surgical processes, and increased confidence in the precise placement of implants for all patients.



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