Viking Systems Inc. (OTC:VKNG) won 510(k) clearance from the Food & Drug Administration for its next-generation 3DHD visualization system.
The Westborough, Mass.-based company said the system, which it designed to provide surgeons with 3D video of minimally invasive procedures, restores the depth perception lost with conventional 2D video systems, with which most minimally invasive procedures are performed.
“We are very pleased to have received timely FDA 510(k) clearance of our Next Gen system for a broad base of minimally invasive procedures including general surgery, urology, gynecology, spinal, bariatric, ENT and thoracic,” Viking CEO Jed Kennedy said in prepared remarks.
The company said it will launch the 3DHD system in October at the American College of Surgeons’ Annual Clinical Congress in Washington D.C.
Kennedy said the company is pursuing CE Mark approval in the European Union and expects to begin marketing and selling the device in Europe during the fourth quarter.
The FDA clearance is good news for Viking, which took out an equity line with Boston, Mass.-based investment fund Dutchess Opportunity Fund II LLP in January to cover the launch of the 3D surgical camera system.
