by Robert Garment and
Amanda Doreson

This article is from in the April 2007 issue of DOTmed Business News. A list of registered users that provide sales & service can be found at the end.


Mobile C-arms -- the name comes from the characteristic "C"-shape all this equipment shares in common -- are radiographic and fluoroscopicsystems with an X-ray tube at one end of the "C" and an image intensifier and charge-coupled device (CCD) camera at the other. They are highly maneuverable and multi-positional, allowing for different angulations of the imaging system around the patient, enabling physicians to see real-time images from virtually any angle.
Invented by Phillips in 1953, the vast majority of C-arms are mobile. Fixed C-arms are sometimes found in special procedure suites. Mini C-arms, originally design for use with the extremities, offer lower cost, a more compact size, and comparable performance of full-size Cs, resulting in the growth of their popularity. C-arms are used for a multitude of normal and emergency room diagnostic procedures. They've also become indispensable tools in non-invasive therapeutic procedures such as arthroscopic surgery to assist in the positioning of plates and screws, and in pain management therapy to guide the placement of needles.

Mobile C-arm market leaders

The majority of the U.S. mobile C-arm market is controlled by a handful of manufacturers, with the leader being GE/OEC. The three other top C-arm companies are Philips Medical, Siemens Medical, and Ziehm Imaging, based in Germany. Ziehm -- currently the leading manufacturer of mobile C-arms in Europe -- is looking to increase its market share in the U.S. with its new Vision FD flat panel detector (FPD) mobile C-arm -- the first digital and mobile with a flat-screen panel. The leading manufacturers of mini C-arms are Hologic (Bedford, MA), OEC and Orthoscan (Sherborn, MA).

The 800 pound gorilla has left the room

It is impossible to discuss C-arms today with industry insiders for more than two minutes without mention of the GE/OEC shutdown. In case you haven't been paying attention, inspections conducted by the FDA during July and August, 2006, revealed CGMP (current good manufacturing practices) deficiencies, including failure to establish and maintain adequate procedures for validating the device design and failure to establish and maintain adequate procedures for implementing corrective and preventive actions at OEC's facilities in Utah and Massachusetts. Manufacturing cannot resume until the problems have been corrected. The consent decree signed by GE/OEC in January 2007 as a result of investigations by the FDA has effectively shut down shipment of OEC products, include the 9900 Elite C-Arm System, 9900 Elite NAV C-Arm System, 9800 C-Arm System, 2800 UroView System, 6800 MiniView System, Insta-Trak 3500 NAV System, and ENTrak 2500 NAV System, as well as their components and accessories.

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