FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

FDA Clears Viseon’s Voyant System

Oct. 19, 2018

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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