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FreeHand laparoscopic camera receives FDA and CE approval

FreeHand

This article has been taken from The Gen newsletter - Summer 2009. Click here to download the pdf.

Over 400 surgical procesures have been undertaken using Prosurgics' FreeHand robotic camera controller since it achieved CE mark accreditation and FDA approval earlier this year.

Following its launch in 2008, FreeHand attracted much interest from surgeons worldwide and immediately went on to win two awards the same year: an Innovation of the Year from the US Society of Laparoendoscopic Surgeons; and the innovation category at ERBI's regional MedTech awards in the UK.

Achieving FDA and CE approval were important final steps in the commercial development of FreeHand, which is now available to surgeons worldwide.

As Prosurgics' key development partner for FreeHand, Sagentia has been heavily involved throughout the design and development of the second generation device, to ensure that stringent specification requirements for performance, safety, size and ergonomics were all met. The unit is more compact, easier to set up and use and more affordable than Prosurgics' first generation product.

FreeHand allows surgeons to directly control the movement of the endoscopic camera during laparoscopic (key-hole) procedures. Its introduction has overcome a number of problems associated with the previous handheld approach, including camera shake and poor image visualisation.

It is also contributing to surgical efficiency by reducing the duration of operations.

The number of surgeons and hospitals adopting FreeHand is growing rapidly. Feedback from users has been overwhelmingly positive.

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