7D Surgical announced it has received FDA 501(k) clearance and a medical device license from Health Canada for its Machine-vision Image Guided Surgery system for spine surgery, the 7D Surgical System.
According to a company press release, the 7D Surgical System uses 3-D optical technologies and machine vision algorithms to eliminate barriers to the adoption of existing surgical navigational platforms. The new technology automatically registers spinal surgery patients using only visible light. The Machine-vision Image Guided Surgery (MGIS) technology is embedded in an onboard overhead surgical light, which eliminates line of sight frustrations in the OR and is operated by the surgeon by a foot pedal.
“When navigating the spine, surgeons traditionally have had two time-consuming and expensive [image-guided surgery] IGS options: systems that rely on intraoperative radiation-emitting devices or systems that utilize laborious manual point matching techniques,” Beau Standish, chief executive officer of 7D Surgical, said in the release. “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.”