Viking Systems Inc. has received the go-ahead from the U.S. Food and Drug Administration (FDA) for clearance of its Next Generation 3DHD visualization system, scheduled for launch in Washington D.C. during the American College of Surgeons’ Annual Clinical Congress, October 3-7.
Viking’s Next Generation 3DHD camera system allows surgeons to perform complex, minimally invasive surgery with an advanced vision system that restores their natural depth perception, a significant improvement from procedures currently performed with a 2D camera. The 3D vision provides surgeons the ability to offer improved care, reduced procedure time, and reduced cost of procedures.
Jed Kennedy, Viking president and CEO, said the FDA clearance positions the company to complete requirements to apply its CE mark to 3DHD, which demonstrates compliance with Europe’s Medical Device Directive.
“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,” Kennedy stated in the press release. “With the 510(k) in place, we will now focus on completing the documentation required to apply the CE mark to the 3DHD system.”
Kennedy said Viking’s ISO13485 certification enables the company to self-certify the 3DHD for the European community, which keeps the company on track to be in the U.S. and European markets in the fourth quarter of 2010.
At last year’s American College of Surgeons’ Annual Clinical Congress in Chicago, Viking made its first public demonstration of its Next Generation 3DHD camera system utilizing a prototype Sony 3DHD flat panel display. Since then, the company has worked with Sony to present the product and its capabilities at a series of Surgical Congresses.
Viking said it plans on producing and shipping its first deliveries of the system in the U.S. and European markets in the fourth quarter of 2010.
For more information visit www.vikingsystems.com
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