The new spinal module will help enhance the functionality of the company’s 7D Flash navigation system
The FDA has approved SeaSpine’s 7D surgical percutaneous spine module. (Credit: kalhh from Pixabay)
Medical technology firm SeaSpine Holdings has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its 7D percutaneous spine module for minimally invasive surgery.
The new spinal module will help increase the functionality of the company’s 7D Flash navigation system, which is designed to improve workflows in surgical procedures.
The approval is said to follow SeaSpine’s recent acquisition of 7D Surgical, a Toronto-based firm that offers optical technologies and machine vision-based registration algorithms for surgical navigation.
SeaSpine is planning a limited launch of the Percutaneous Spine Module in the third quarter of this year.
SeaSpine enabling technologies president Beau Standish said: “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 centers and hospitals. I’m very proud of what our team has accomplished thus far, but this is still just the beginning of where we will take our machine vision technology in the future.”
Using visible light, the 7D Flash navigation system generates a three-dimensional image to enable surgical navigation within seconds. It will help to complete spinal procedures quickly and efficiently.
SeaSpine7D Flash is claimed to be the only regulatory-cleared image guidance system, which uses camera-based technology along with machine-vision algorithms to avoid issues with legacy surgical navigation platforms.
SeaSpine president and CEO Keith Valentine said: “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.”