Viseon Gains FDA Clearance for Voyant Imaging for MIS Spine

By Julie A. Vetalice

Viseon  announced an additional FDA 510(k) clearance and initial clinical use of Voyant, an integration of minimally invasive surgical (MIS) access with real-time high-definition imaging technology. Limited launch will commence in 1Q20, with full market release to come in 2H20.

Viseon is a single-use, disposable alternative to surgical microscopes, endoscopes and loupes for use in posterior and lateral access MIS spine procedures. It projects the operative field onto a flat panel display within the O.R. and to remote locations to involve the entire O.R. staff, while offering training opportunities as well.

The purpose of this additional submission was to implement design changes for a product line extension which includes the Voyant Sheath retractor, Voyant Imager and accessories.
Over coming months, Viseon plans to complete a clinical usage study utilizing the Voyant System in posterior access and lateral access fusion.

Source: Viseon, Inc.

Viseon, Inc. - ORTHOWORLD


Tags: 510(k) Clearance, Regulatory