MAZOR’s SpineAssist / C-Insight Combined Spinal Surgical System Gets Green Light in US

Israel’s business newspaper Globes is reporting that MAZOR Surgical Technologies has received approval from the FDA for the company’s combined SpineAssist navigation and C-Insight imaging system. As we have reported before, Mazor’s SpineAssist device is a miniature robotic guidance / perioperative planning system designed for treatments of spinal compression fractures and other vertebral surgical issues.
From the product pages:

SpineAssist
The system consists of a miniature device that mounts above the patient’s spine, and a workstation running advanced surgical planning software.
SpineAssist’s software allows surgeons to perform 3D, CT- based preoperative planning on a personal computer at their own convenience prior to surgery.
Using a virtual catalogue of surgical implants, surgeons can view and position implants within each vertebra or disc on three planes: AP, lateral and axial. A special feature in the software is used to review the planning slice by slice in sequence.
The software supports a range of measurements including Cobb angle, lordosis and kyphosis. The surgeon can view a simulation of the correction they are planning, which is especially useful in deformity and scoliosis cases. The software also calculates rod length and curvature.
The SpineAssist workstation connects to a fluoroscopic C-Arm and performs automatic CT-to-fluoroscopy image registration based upon 2 fluoroscopic images. The workstation is used to control the precise motion of the miniature device to the preplanned position.
C-InSight
C-InSight is an add-on to existing C-Arms, converting 2D scans to 3D images intraoperatively.
In line with FDA guidelines for radiation reduction, C-InSight provides 3D images at radiation exposure levels as low as 5%-10% of other intraoperative 3D scans, making is safer for both the OR team and patients. C-InSight can often eliminate the need for a post-operative CT scan.
C-InSight quickly connects to any C-Arm with a video output (via BNC cable) and converts 2D scans to 3D images in 2 minutes.
A short in-service will get the OR technicians / staff ready to operate the C-InSight. The easy step-by-step instructions assure consistent performance.

Here’s Ori Hadomi, CEO of Mazor explaining the system on Fox Business News:

Demo video of C-InSight:

SpineAssist promo:

Globes: Mazor wins FDA nod for combined surgical systems…
Product pages: SpineAssist; C-InSight…
Flashback: SpineAssist Gets New FDA Approval