Canada-based 7D Surgical has secured 510(k) clearance from the US Food and Drug Administration (FDA), as well as the Health Canada medical device license (MDL) for its Cranial Biopsy Kit.
Cranial Biopsy Kit enables neurosurgeons to employ image guidance to precisely target brain lesions during needle biopsy procedures.
The Toronto-based firm has announced the commercial launch of the Universal Tracking Kit to support a series of surgical instruments.
Universal Tracking Kit can be utilised by spine surgeons to track and visualise any rigid surgical instrument on the MvIGS system, including third-party vendor taps and screwdrivers.
7D Surgical CEO Beau Standish said: “7D Surgical has successfully transitioned from a start-up organisation 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.
“2020 will be another break out year for our Machine-Vision innovations and continued North American and international expansion.”
The FDA 510(k)-cleared and Health Canada approved MvIGS system is for use in surgical workflows during spine and cranial surgeries.
Featuring camera-based technology and machine vision algorithms, MvIGS system addresses issues associated with legacy surgical navigational platforms.
Visible light is used by the MvIGS system, helping to avoid patient and staff exposure to intraoperative radiation seen in 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.”
In January 2017, 7D Surgical had received the FDA 510(k) clearance and Health Canada medical device license (MDL) for use of its Machine-Vision Image-Guided Surgery (MIGS) system in spine surgery.