Stryker’s Q Guidance System OK’ed for Cranial Applications

Stryker has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Q Guidance System with Cranial Guidance Software.
 
The Q Guidance System provides image-based planning and intraoperative guidance to support cranial surgeries. The Q Guidance System for spinal applications was launched in September 2022.
 
The new cranial application is indicated for any medical condition where use of computer-assisted planning and surgery is appropriate and can be used for intraoperative where a reference to a rigid anatomical structure can be identified. It tracks navigated instruments and shows position and orientation of instruments in patient images.
 
The Cranial Guidance Software also features automatic, algorithmic processing and comprehensive guidance data to elevate confidence and surgical ability.
 
“The FDA clearance of Stryker’s Q Guidance System with Cranial Guidance Software is a key milestone, which will help lead the transformation of cranial navigation and surgery,” Robbie Robinson, president of Stryker’s Spine division told the press. “Our robust pipeline of iterative launches reinforces our commitment to making industry-leading investments focused on providing advanced navigation products and differentiated technologies that our surgeon customers have come to expect.”
 
The software can be used with a range of instruments and accessories for navigated cranial procedures. New for brain biopsies, the software offers dedicated workflow to support accurate alignment of the Precision Targeting System with a preoperatively planned approach.
 
Stryker also leverages plug-in electromagnetic (EM) tracking tech for both adults and children to place shunt catheters, which can be visualized with an EM Stylet.