FDA and Health Canada approval for Machine-vision Image Guided Surgery (MIGS) system for spinal surgery.- 7D Surgical
7D Surgical announced that it has received both 510(k) clearance from the FDA and a medical device license from Health Canada enabling the North American commercial launch of its innovative Machine-vision Image Guided Surgery (MIGS) system for spine surgery, the 7D Surgical System.
The 7D Surgical System employs cutting-edge 3D optical technologies and machine vision algorithms to eliminate the long-standing barriers to adoption of existing surgical navigational platforms. 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 an incredibly fast surgical workflow for spine procedures.
The MIGS navigation technology is embedded in an on-board overhead surgical light, which is designed to eliminate line-of-sight frustrations in the operating room which is controlled by the surgeon using only a foot pedal.
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