Toronto-based 7D Surgical has secured 510(k) clearance from the US Food and Drug Administration (FDA), as well as a medical device licence from Health Canada for its Cranial Biopsy Kit.
The Cranial Biopsy Kit enables neurosurgeons to apply image guidance to precisely target brain lesions during needle biopsy procedures.
7D Surgical has also launched Universal Tracking Kit
The company has also announced the commercial launch of the Universal Tracking Kit to support a range of surgical instruments.
7D Surgical CEO Beau Standish said: “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 commercialising these latest products in the spine and cranial markets.
7D Surgical’s Universal Tracking Kit can be used by spine surgeons to track and visualise any rigid surgical instrument on the MvIGS system, including third-party vendor taps and screwdrivers.
The FDA 510(k)-cleared and Health Canada approved MvIGS system is used in surgical workflows during spine and cranial surgeries.
The MvIGS system features completely new camera-based technology and machine vision algorithms to address the issues associated with legacy surgical navigational platforms.
The visible light is used by the MvIGS system, helping to avoid the patient and staff exposure to intraoperative radiation that is prevalent with older technologies.
7D Surgical sales and marketing vice-president Brian Stuart said: “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 expand the functionality of the MvIGS system while maintaining our clear advantages in speed and reduced radiation exposure to operating room staff and patients.”
7D Surgical is involved in the development of advanced optical technologies and machine vision-based registration algorithms to optimise surgical workflow and patient care.
In January 2017, 7D Surgical secured 510(k) clearance from the FDA and a medical device license from Health Canada for its machine-vision image guided surgery (MIGS) system to be used for spine surgery.
