7D Surgical wins FDA, Health Canada nod for spinal surgical guidance system

Canadian medical device firm 7D Surgical said today it won FDA 510(k) and Health Canada clearance for its machine-vision image guided 7D Surgical navigation system designed for spinal procedures.

The Toronto-based company’s surgical system uses 3D optical technologies which require only natural light, as well as machine vision algorithms. 7D Surgical touted the system as eliminating barriers to adoption for existing surgical navigation platforms, and can help speed up surgical workflow for spinal procedures.

“Image guided surgery technology has finally caught up to the needs of a practicing spine surgeon. 7D Surgical’s new MIGS system appears to provide a faster, radiation-free alternative to existing options. It could be an important new tool in expanding the use of IGS in spine procedures. The 7D Surgical System reduces the overall cost and footprint required to navigate the spine. It’s a win-win for the surgeon and the hospital,” Dr. Frank Cammisa of New York’s Hospital for Special Surgery said in prepared remarks.

The system’s navigation technology is embedded in an overhead surgical light to reduce line of sight issues, and is controlled by the surgeon using a foot pedal to eliminate the need for non-sterile personnel for operation.

“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. We are delighted to have achieved these regulatory milestones in line with our expectations and planning. We are confident that in demonstrating the speed and efficiency of our MIGS system, we will convince more surgeons to employ IGS in their spine procedures,” CEO Beau Standish said in a press release.

“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,” chief scientific officer & prez Dr. Victor Yang said in a prepared statement.

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