Early stage, spinal-focused medical device maker Viseon said today it won FDA 510(k) clearance for its minimally-invasive Voyant system intended for accessing, visualizing and illuminating spinal procedures.
The Voyant system is composed of a sterile single-use, disposable retractor device featuring integrated visualization technology and a reusable controller for manipulation of the surgical site image.
The system is designed to display images on existing operating room display monitors, and the sterile device component allows for the adjustment of interoperative depth of focus, the Irvine, Calif.-based company said.
“We believe the primary factor contributing to spine surgeons’ slow adoption of minimally invasive spine surgery has been inconsistent outcomes driven by the limited or lack of direct access to and visibility of the surgical anatomy. Traditional capital-intensive surgical microscopes and loupes have been in use for many years, and Viseon is offering state-of-the-art technology as a simple alternative,” prez & CEO Jeffrey Valko said in a prepared statement.
“This system offers an alternative to surgical microscope and surgical loupes visualization for many minimally invasive spine surgery procedures, eliminating ergonomic consequences and multiple scope repositioning maneuvers and refocusing. It also is useful teaching in the OR, since everyone can see and learn from the procedure,” Dr. John Liu of USC’s Keck School of Medicine said in a press release.
Last Sepbember, Viseon said it closed a $5 million Series-A financing round.