FDA clears Viseon’s Voyant spine surgery imaging device

Viseon said today that it won FDA clearance for its Voyant system for integrating minimally invasive surgical access with high-definition imaging technology.
Irvine, Calif.-based Viseon’s Voyant technology is billed as an alternative to surgical microscopes, endoscopes and loupes, designed for use in both posterior and lateral-access minimally invasive spine procedures.
With real-time, high-definition imaging technology, the Voyant system is designed for more efficient procedural workflow, enhancing intraoperative visualization with an unobstructed view of the operative field.
Viseon said it plans to complete a clinical usage study with the Voyant system with emphasis posterior and lateral-access procedures. It also intends to complete limited commercialization of the Voyant system by the end of the first quarter 2020, while full market release is slated for the second half of 2020.
The company closed a $5 million Series A funding round in September 2017 for the MIS technology, then won FDA 510(k) clearance for the Voyant system in October 2018.
“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,” CEO Jeff Valko said in prepared remarks. “This application alone has game-changing potential for lateral access market leadership differentiation. We have also developed the system for use during posterior lumbar access, integrated onto minimally invasive tubular retractors.”
“The ease of use with this system, enabling the entire OR staff to observe, was a large contributor to our success in this case,” added University of Virginia department of neurosurgery assistant professor Dr. Avery Buchholz. “The light and image quality with Voyant were excellent. We were able to get the patient off the table quickly and did very well.”
Original Article: (https://www.massdevice.com/fda-clears-viseons-voyant-spine-surgery-imaging-device/)