7D Surgical announced today important additions to its cranial and spinal product lines. The company has received both 510(k) clearance from the U.S. Food and Drug Administration (FDA) and a medical device license from Health Canada for its Cranial Biopsy Kit, which allows neurosurgeons to use image guidance to accurately target brain lesions during needle biopsy procedures.
In their effort to support a wide range of surgical instruments, 7D Surgical is also announcing the commercial release of its Universal Tracking Kit which spine surgeons can use to track and visualize almost any rigid surgical instrument on the MvIGS system, including third-party vendor taps and screwdrivers.
“7D Surgical has successfully transitioned from a start-up organization to a growth company, having launched more than 33 MvIGS programs since our full commercial release a little over a year ago. We are very proud of our team for commercializing these latest products in the spine and cranial markets,” said Beau Standish, CEO of 7D Surgical. “2020 will be another break out year for our Machine-Vision innovations and continued North American and international expansion.”
The 7D Surgical MvIGS system utilizes completely new camera-based technology and machine vision algorithms to eliminate the long-standing frustrations with legacy surgical navigational platforms. The system uses only visible light, eliminating the patient and staff exposure to intraoperative radiation which is common with older technologies. This results in a nearly instantaneous patient registration in almost any surgical position.
“We have completed more than 1,500 clinical cases with the 7D Surgical System and the feedback from our surgeon users has been tremendous. I am excited to offer these new technologies to our customer base which expands the functionality of the MvIGS system while maintaining our clear advantages in speed and reduced radiation exposure to operating room staff and patients,” said Brian Stuart, Vice-President of Sales & Marketing at 7D Surgical.