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Mazor Surgical Technologies

17-08-2008
Mazor Surgical Technologies Receives FDA Clearance For Its C-Insight™ System

C-InSight – creating 3D from 2D X-ray images

August 17, 2008, Caesarea, Israel and Atlanta, GA – Mazor Surgical Technologies Ltd. announced that it received clearance from the Food and Drug Administration (FDA), for its CInSight System. The C-InSight System is an inter-operative imaging system creating three dimensional images, based on two-dimensional X-rays. The product is a software base product which transforms two dimensional images taken in the operation rooms by existing OR X-Ray (C-Arm) equipment during spine and orthopedic surgery, into three dimensional images.

C-InSight is a software base product thereby eliminating the need to purchase additional expensive hardware to obtain 3D images in the operating room. Surgeons will be able to view in 3D the placement of implants and fracture repairs, enabling to accurately confirm the surgery results.

The clearance received from the FDA is a significant milestone in the development and marketing of the C-InSight System. Next steps include beta tests of the system in the US, Israel and Germany, to ensure that workflow fits smoothly into the many different OR environments around the world. .

“C-InSight will be launched during the North American Spine Society meeting in Toronto, Canada, scheduled October 14-17, 2008. We expect C-InSight to be commercially available early 2009”, commented Ori Hadomi, CEO, Mazor Surgical Technologies Ltd. “During our field tests, surgeons confirmed that the third dimension is key to ensuring the best clinical outcome. We are glad to be able to offer such a product to the market at a reasonable price.


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