by
Keith Loria, Reporter | June 19, 2009
This report originally appeared in the April 2009 issue of DOTmed Business News
May 5 of 2008 was a monumental day in the C-arms world, as for the second time in as many years, GE Healthcare and its OEC surgery business rocked the very foundation of the entire C-arms landscape.
Let's rewind back to January of 2007 when the FDA revealed that the current good manufacturing practices with the OEC C-arm were deficient at two OEC facilities, which resulted in a consent decree that effectively shut down shipments of the industry-leading OEC products, including 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.

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While this may have seemed like good news to the other OEMs, the sudden influx of orders created some chaos and supply problems. Philips came away with the lion's share of the business thanks to their introduction of their new generation of C-arms, which included the Pulsera, offering 3D imaging.
"Just when we finished developing Pulsera to the new platform, GE had the consent decree and shut down operations for 18 months," says Scott Burkhart, Vice President of general X-ray for Philips. "Three years ago we were a relatively minor player and we really set about to fix image quality and be world class in image quality, which was accomplished."
But everything changed again last May when GE/OEC was cleared to release some of its product and began manufacturing the popular OEC 9900 C-Arms once again. Even though they have still yet to get clearance for their vascular or mini C-arms, their return has changed the entire marketplace for both new and refurbished equipment once more.
"We came back in May with the OEC 9900 Elite, the most reliable product in our history, and sales have been great," says Elizabeth Usher, Chief Marketing Officer for GE Healthcare Surgery. "We see growth in the market in 2008 primarily driven by our re-entry."
In the full size C-arm market, GE reports high single-digit market growth and the capture of more than 40% share of this specific segment in 2008, climbing even higher in the year's final quarter.