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OnPoint Surgical Announces 510(k) Clearance from FDA For Augmented Reality Spine System


The device used a headset with a virtual display to provide information to surgeons during procedures.

The FDA has granted 510(k) clearance to OnPoint Surgical’s Augmented Reality Spine System.

In a press release, vice chair of neurosurgery, director of spinal neurosurgery, co-director of comprehensive spine surgery at Brigham and Women’s Hospital, Harvard Medical School, Dr. Michael Groff said, “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. 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. We are thrilled to offer this unique technology to our patients in the near future.”

The device is able to provide surgeons with information through the use of a display attached to a headset.

OnPoint stated in a press release that the 510(k) will allow the company to make the system available nationwide.

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