Viking’s 3DHD visualisation system gets FDA nod
This article was originally published in Clinica
Executive Summary
The FDA has granted 510(k) clearance for Viking Systems’ next-generation 3DHD visualisation system. The product is designed for use during minimally-invasive surgery, including urology, gynaecology and spinal procedures. Currently, most of these operations are carried out with a 2D camera, Viking claims. It believes that its device could improve the quality of care, as well as reducing procedure time and therefore costs. The Westborough, Massachusetts firm plans to launch the system at the annual meeting of the American College of Surgeons, to be held on 3-7 October in Washington, DC. Viking is also planning to CE mark the device for sale in Europe by the end of the year.