Regulatory

VISEON, Inc. Announces FDA Clearance of the Voyant System for Minimally Invasive Spine Surgery Access, Visualization, and Illumination

October 18, 2018

IRVINE, Calif.–(BUSINESS WIRE)–Viseon, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their Voyant System for Minimally Invasive Spine Surgery, featuring proprietary HD imaging sensor and illumination technology. The Voyant System is composed of a sterile single-use, disposable retractor device with integrated state-of-the-art visualization technology, and a reusable controller enabling digital intraoperative manipulation of the surgical site image, displayed on existing operating room HD flat-panel display monitors. The sterile device also allows the surgeon to adjust intraoperative depth of focus.

Viseon President and CEO Jeffrey Valko stated, “We believe the primary factor contributing to spine surgeons’ slow adoption of minimally invasive spine surgery has been inconsistent outcomes driven by the limited or lack of direct access to and visibility of the surgical anatomy. Traditional capital-intensive surgical microscopes and loupes have been in use for many years, and Viseon is offering state-of-the-art technology as a simple alternative.”

John Liu, MD, professor of clinical neurological surgery at the Keck School of Medicine of USC commented, “This system offers an alternative to surgical microscope and surgical loupes visualization for many minimally invasive spine surgery procedures, eliminating ergonomic consequences and multiple scope repositioning maneuvers and refocusing. It also is useful teaching in the OR, since everyone can see and learn from the procedure.”

About Viseon, Inc.

Viseon has developed a platform technology that has multiple opportunities for technological expansion, including wireless, neuro-monitoring and navigation, fluorescence, sensor integration and complementary robotic applications. The company has demonstrated clinical utility in posterior lumbar decompression and interbody fusion procedures and is expanding into lumbar lateral access and anterior cervical decompression fusion applications. The privately held medical device company is located in Irvine, California, founded in 2017, and recently completed an oversubscribed follow-on financing in October 2018.

For further information, please visit www.viseon-spine.com.

Contacts

Viseon, Inc.
Jeffrey J. Valko, (949) 662-3959

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Mason Krell

Mason began his career in the Orthopedic Industry in 2017 when he joined The De Angelis Group as a Research Manager. He has developed a strong network within the industry and is very dedicated to helping companies maximize opportunities and disrupt markets.

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