7D Surgical has received FDA 510(k) clearance for its machine-vision image guided surgery (MIGS) system for spine surgery, the 7D Surgical System. The FDA-cleared system employs advanced 3D optical technologies and machine vision algorithms to eliminate the long-standing barriers to adoption of existing surgical navigational platforms. In fact, this new technology can easily register spinal surgery patients automatically using only visible light.
Unlike time-consuming conventional image-guided surgery (IGS) systems that depend on intraoperative radiation, this new platform can achieve a fast surgical workflow for spine procedures.
“When navigating the spine, surgeons traditionally have had two time-consuming and expensive IGS options: systems that rely on intraoperative radiation emitting devices or systems that utilize laborious manual point-matching techniques,” says Beau Standish, CEO of 7D Surgical. “We believe the inefficiencies of these systems have limited the adoption of IGS in spine procedures to less than 20%. 7D Surgical’s MIGS system has now removed these barriers, providing surgeons and their hospitals with a superior product option.”
According to 7D Surgical officials, the FDA-cleared system enables near-instantaneous Flash Registration™ of the patient’s anatomy. What’s more, the MIGS navigation technology is embedded in an onboard overhead surgical light, which eliminates line of sight frustrations in the operating room, and is manifested in software controlled by the surgeon using only a foot pedal.
For more information regarding this product, visit 7D Surgical.