Business Wire10.18.18
Viseon Inc. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their Voyant System for Minimally Invasive Spine Surgery, featuring proprietary HD imaging sensor and illumination technology. The Voyant System is composed of a sterile single-use, disposable retractor device with integrated state-of-the-art visualization technology, and a reusable controller enabling digital intraoperative manipulation of the surgical site image, displayed on existing operating room HD flat-panel display monitors. The sterile device also allows the surgeon to adjust intraoperative depth of focus.
Viseon president and CEO Jeffrey Valko stated, “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.”
John Liu, M.D., professor of clinical neurological surgery at the Keck School of Medicine of USC commented, “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.”
Viseon president and CEO Jeffrey Valko stated, “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.”
John Liu, M.D., professor of clinical neurological surgery at the Keck School of Medicine of USC commented, “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.”