Viseon received a 510(k) clearance from the FDA for its Voyant System for minimally invasive spine surgeries, including proprietary HD imaging and illumination.
The system is billed as an alternative to the use of surgical microscopes or glasses-mounted loupes, displaying the image on the operating room’s flat-panel display monitors.
Its sterile, single-use retractor is paired with a reusable digital controller that allows the surgeon to adjust the image and its depth of focus during the procedure, without additional repositioning or refocusing.
“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,” Viseon President and CEO Jeffrey Valko said in a statement.
The Irvine, California-based company’s system also aids in OR instruction, by allowing multiple people to view the details of the procedure.
Viseon was spun out of Rebound Therapeutics in early 2017, and raised $5 million last year in a series A round, led by HBM-MedFocus, Invus Opportunities Fund and affiliates of Wexford Capital LP.