7D Surgical Receives US and Canada Regulatory Clearance for Spinal Image Guidance System

By Julie A. Vetalice

7D Surgical received both FDA 510(k) clearance and a medical device license from Health Canada to market MvIGS™, the Machine-vision Image Guided Surgery system.

The system employs 3D optical technologies and machine vision algorithms, registering spinal surgery patients automatically with near-instantaneous Flash Registration™ using only visible light to support an overall workflow time of less than 20 seconds for de novo spinal registration. This contrasts conventional methods that rely on intra-op radiation, and may require 30 minutes of registration time.

MvIGS navigation technology is embedded in an onboard, overhead surgical light, and the software itself is surgeon-controlled via foot pedal.

In a similar vein, Royal Philips is developing augmented-reality surgical navigation technology for use in image-guided open and minimally invasive spine procedures. This approach creates an internal 3D view acquired by x-ray.

Sources: 7D Surgical; ORTHOWORLD Inc.

Product Labels: Surgical Navigation

Tags: 510(k) Clearance, Regulatory