FDA Clears Real-Time Imaging Tech for Spine Surgery

Viseon today announced that the U.S. Food and Drug Administration cleared the use of its Voyant System, which aims to give clinicians a more accurate and precise view of the operative field during minimally invasive surgery.

The company also announced the initial clinical use of the Voyant System.

The system integrates minimally invasive surgery access with real-time, high definition imaging technology for more efficient procedural workflow.

The Voyant System is composed of a single-use, disposable alternative to surgical microscopes, endoscopes and loupes, with integrated visualization technology and a reusable controller to enable digital intraoperative manipulation of the surgical site image. The operative field projects onto a flat panel display within the operating room and to remote locations.

That feature, Viseon claims, allows full staff involvement during the procedures and offers opportunities for teaching and training.

“One of our major goals is to address the unmet clinical need for enhanced visualization during state-of-the-art minimally invasive lateral access lumbar fusion procedures,” said Jeff Valko, CEO at Viseon. “This application alone has game-changing potential for lateral access market leadership differentiation.”

The technology was developed for use in posterior and lateral access minimally invasive spine procedures.

Viseon hopes to complete a clinical study over the next few months using Voyant for both types of procedures.

The system has been used by professionals at the University of Virginia, who said the system was easy to use and helped get the patient off the table quickly.

Viseon also plans for limited commercialization of the system by the end of the first quarter 2020 and full market release for the second half of next year.

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