Image Guidance Surgery System Awarded US and Canada Clearance

An innovative spinal surgery platform has received US 510(k) clearance, and a medical device license from Health Canada.

The system uses 3D optical technologies and machine vision algorithms to help register spinal surgery patients automatically. The system uses visible light and is intended to replace conventional Image-Guided Surgery (IGS) systems that require intraoperative radiation.

Regulatory clearance of the Machine-vision Image Guided Surgery (MIGS) platform was announced by 7D Surgical and will enable the commercial launch of the system in North American. Prototype MIGS technology has been used in clinical trials involving more than 160 patients at the Sunnybrook Health Sciences Centre.

The 7D Surgical system requires less than 20 seconds for de novo spinal registration, compared to current spinal IGS system, which require registration times of up to 30 minutes during surgery. The MIGS system is embedded in an onboard overhead surgical light preventing line-of-sight problems for surgeons in the operating room. The MIGS software is controlled by a surgeon using a foot pedal.

CEO of 7D Surgical, 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.”