FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

FDA Clears Viseon’s Voyant System

Oct. 19, 2018
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Viseon’s Voyant system received 510(k) clearance for use in minimally invasive spinal surgery access, visualization and illumination.

The device includes HD imaging sensor and illumination technology, and consists of a single-use sterile disposable retractor and a reusable controller for moving the site image.

The system allows surgeons to change the depth of focus and view the surgical site on HD flat-panel display monitors in the operating room.

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