FDA Clears Viseon’s MIS Spine Surgery System

Viseon, Inc. has announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Voyant System for Minimally Invasive Spine Surgery, which features proprietary HD imaging sensor and illumination technology.

The Voyant System consists of a single-use sterile disposable retractor device and a reusable controller for moving the site image. The system allows surgeons to change the depth of focus and to view the surgical site on HD flat-panel display monitors in the operating room.

According to the Company, the Voyant system gives spine surgeons an alternative to the use of surgical microscopes or glass-mounted loupes for minimally invasive spine procedures. Interestingly, the system lets multiple people view the details of the procedure.

Viseon President and CEO Jeffrey Valko 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.”

“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.

Viseon is a privately held medical device company in Irvine, California that focuses on the spine. The company was spun out of Rebound Therapeutics in early 2017. Viseon said it raised $5 million last year in a series A financing round, which was led by HBM-MedFocus, Invus Opportunities Fund, and affiliates of Wexford Capital LP.