Prosurgics Limited announced that its FreeHand next generation laparoscopic camera controller has received 510(k) clearance from the FDA, allowing the company to commence sales activities for the product in the US market.
FreeHand provides laparoscopic surgeons with improved visualisation throughout the procedure and addresses the scarcity and the cost of good camera assistants. Prosurgics commenced deliveries of FreeHand in Europe during February 2009, where a growing number of surgeons and hospitals are now enjoying its benefits. Prosurgics is focused on bringing high-value robotic solutions to surgical challenges in an affordable manner to a multi-specialty, global market.
Bill Perry, President of Prosurgics Inc., commented, Experience in Europe over the past months has demonstrated the demand for FreeHand from all disciplines of laparoscopic surgery. We believe that US surgeons will be even faster in adopting this new technology; the message we are getting is very clear — Freehand addresses real needs, simply and affordably. With strong interest from a large number of leading institutions I am excited by the prospects for rapid penetration of this market of 1.5 million procedures annually. Providing surgeons direct control of the scope, procedural time savings and a rock steady viewing image has proven very attractive.