7D Surgical has secured 510(k) clearance from the US Food and Drug Administration (FDA) and a medical device license from Health Canada for its machine-vision image guided surgery (MIGS) system to be used for spine surgery.
The surgical system features advanced 3D optical technologies and machine vision algorithms, which allows to eliminate barriers to adopt existing surgical navigational platforms.
It is said to enable near-instantaneous flash registration of the patient’s anatomy, and holds capacity to achieve enhanced workflow for spine procedures.
MIGS navigation technology is embedded in an onboard overhead surgical light, which helps to eradicate sight disturbances in the operating room.
7D Surgical CEO Beau Standish said: “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.
“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.”
7D Surgical president and chief scientific officer Dr Victor Yang said: “Guided by our product philosophy of ‘surgeons designing for surgeons,’ we have achieved an unprecedented entire workflow time of less than 20 seconds for de novo spinal registration, unheard of in the spinal IGS world where such registration can interrupt surgery for up to 30 minutes.”
7D Surgical is engaged in the development of optical technologies and machine vision-based registration algorithms for enhanced surgical workflow.
Image: 7D Surgical’s its machine-vision image guided surgery system has been approved in the US and Canada. Photo: courtesy of 7D Surgical.