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Voyant System Gets 501(k) Clearance for Spine Surgery
On October 18, the FDA granted 501(k) clearance to Viseon Inc.’s (Irvine, California) Voyant System for minimally invasive spine surgery. The system displays high-definition (HD) surgical images on flat-screen monitors in operating rooms and enables the surgeon to adjust the image and focus, thanks to a reusable digital controller, which is paired with a sterile, single-use retractor.
Spine surgeons have been slow to adopt minimally invasive spine surgery. One reason could be a lack of consistency in outcomes because of limited visibility during the procedures.
With its proprietary HD imaging and illumination, the new system will provide an alternative to the type of visualization offered by the traditional surgical microscope and loupe. Besides eliminating the need to frequently reposition and refocus scopes, Voyant may prove useful for teaching purposes as the system will enable anyone who is in the OR during surgery to garner details from the procedure.\
Source: FierceBiotech, October 22, 2018