SeaSpine this week said it received FDA 510(k) clearance for its 7D Percutaneous Spine Module.
Carlsbad, Calif.-based SeaSpine designed the spine module for minimally invasive surgery. It adds increased functionality for its 7D Flash Navigation System, which follows SeaSpine’s recent acquisition of 7D Surgical.
“We are extremely excited to achieve FDA clearance and eager to deploy our Percutaneous Spine Module,” Beau Standish, president of enabling technologies at SeaSpine, said in a news release. “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.”
The 7D Flash navigation system uses visible light to create three-dimensional images for surgical navigation within seconds. The image guidance system also uses camera-based technology and machine-vision algorithms.
“We are very happy with the integration of 7D Surgical into the SeaSpine family,” 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.”
SeaSpine plans to fully launch the Percutaneous Spine Module in the third quarter of this year.