The spine module was previously granted FDA 510(k) approval, Health Canada MDL approval and CE Mark for spinal navigation
SeaSpine Holdings, a US-based firm focused on surgical solutions for spinal disorders, has received the FDA 510(k) clearance for its 7D Percutaneous Spine Module for minimally invasive surgery.
The FDA approval follows the company’s recent acquisition of 7D Surgical and enhances the application and functionality for its 7D Flash Navigation System.
7D Surgical is a Toronto-based developer of advanced optical technologies and machine vision-based registration algorithms for surgical navigation to improve patient care.
The 7D FLASH Navigation System has been designed to enhance workflows in surgical procedures.
The spine module was previously granted FDA 510(k) approval, Health Canada MDL approval and CE Mark for spinal navigation.
It leverages visible light to create a three-dimensional image for surgical navigation to facilitate shorter and effective spinal procedures.
The medical technology firm is planning for a limited release of the 7D Percutaneous Spine Module in the third quarter of this year.
SeaSpine enabling technologies president Beau Standish said: “We are extremely excited to achieve FDA clearance and eager to deploy our Percutaneous Spine Module.
“This new application will help address an important part of the spine navigation market and will nicely round out our FLASH Navigation Spine portfolio.
“We anticipate this MIS application to be a valuable enhancement for both ambulatory surgery centres and hospitals.”
SeaSpine said that 7D FLASH Navigation System is the only regulatory-approved image guidance system that combines camera-based technology with machine-vision algorithms.
Also, it offers significant economic value, harnesses the potential of image-guided navigation and mitigates the issues associated with legacy surgical navigation platforms.
SeaSpine president and CEO Keith Valentine said: “We are very happy with the integration of 7D Surgical into the SeaSpine family.
“This is the first new product introduction as a combined team and continues to demonstrate our innovative philosophy and approach to improve spine surgery and deliver clinical value to the surgeon, staff, and patient.
“We believe that participation in the full continuum of care for each patient will deliver clinical value and accelerate our market-share taking strategy.”