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Reimbursement / Regulatory

VISEON Gains FDA Clearance for Voyant Surgical Platform -

Viseon received FDA 510(k) clearance to market the Voyant System for Minimally Invasive Spine Surgery access, visualization and illumination. Voyant is designed to offer an alternative to high capital microscopes and loupes. It combines a sterile, single-use disposable retractor with integrated visualization and a reusable controller that supports digital intraoperative manipulation of the surgical site image which is displayed on existing operating room HD flat-panel display monitors. The sterile device also lets the surgeon adjust depth of focus. (Viseon, Inc., 10/18/18)