Canadian medical device firm 7D Surgical said yesterday it won FDA 510(k) clearance for a Cranial Module for its Machine-vision Image Guided Surgery system.
The Toronto-based company’s 7D Surgical System uses 3D optical technologies which require only natural light, as well as machine vision algorithms.
The system’s navigation technology is embedded in an overhead surgical light to reduce line of sight issues, and is controlled by the surgeon using a foot pedal to eliminate the need for non-sterile personnel for operation.
“We are incredibly excited to expand the MvIGS technology to cranial surgery. The speed, accuracy and efficiency of this new application, coupled with astounding workflow and safety improvements we have already introduced for spinal image guidance, has resulted in a very compelling and cost-effective solution for surgeons and hospitals. Faster, better and cheaper is the new mantra in healthcare and the 7D Surgical System is perfectly positioned to meet these goals,” CEO Beau Standish said in a prepared statement.
The new module is designed to acquire thousands of virtual fiducials using the patient’s own anatomy, and allows for “nearly instantaneous” cranial registration, 7D Surgical said. The system can also register multiple datasets independently, and allows for the visualization of anatomy in multiple modalities.
“This approval allows our team to offer new cranial functionality alongside our game changing spinal application to our existing and planned installations in the U.S. hospitals have been asking us for cranial, and I am delighted to be able to offer this exciting application ahead of schedule and at a price point consistent with our value proposition,” sales & marketing VP Brian Stuart said in a press release.