SeaSpine Gains FDA 510(k) Clearance of 7D Surgical Percutaneous Spine Module for Minimally Invasive Surgery

By Julie A. Vetalice and wire services

SeaSpine Gains FDA 510(k) Clearance of 7D Surgical Percutaneous Spine Module for Minimally Invasive Surgery

SeaSpine announced FDA 510(k) clearance of its 7D Percutaneous Spine Module for minimally invasive surgery. This represents a new application and increased functionality for its 7D Flash™ Navigation System. This news follows SeaSpine’s recent acquisition of 7D Surgical, a Toronto-based company that develops advanced optical technologies and machine vision-based registration algorithms for surgical navigation to improve patient care. The Company is preparing a limited release of the Percutaneous Spine Module in the third quarter.

The 7D FLASH Navigation System uses visible light to create a three-dimensional image for surgical navigation in just seconds, which is expected to result in shorter and more efficient spinal procedures. It is the only regulatory-cleared image guidance system that utilizes this novel and proprietary camera-based technology, coupled with machine-vision algorithms, to eliminate the long-standing frustrations with legacy surgical navigation platforms. The speed, accuracy, and efficiency of machine-vision technology is intended to provide significant economic value and harnesses the true potential of image guided navigation surgery.

The 7D FLASH Navigation System is designed to improve workflows in surgical procedures. The Spine Module has FDA 510(k) clearance, Health Canada MDL approval, and CE Mark for spinal navigation. The Percutaneous Spine Module has FDA 510(k) clearance for spinal navigation. The Cranial Module has FDA 510(k) clearance and Health Canada MDL approval for cranial navigation.

“We are extremely excited to achieve FDA clearance and eager to deploy our Percutaneous Spine Module,” said Beau Standish, President of Enabling Technologies at SeaSpine. “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.”

Source: SeaSpine

Product Labels: Surgical Navigation

Tags: 510(k) Clearance, Regulatory