FDA Gives Green Light To GE Healthcare Surgery; Shipping Resumes

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals;  MRI / PET / Ultrasound
Article Date: 05 Jun 2008 - 5:00 PST

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The United States Food and Drug Administration (FDA) has notified GE Healthcare's Surgery business, headquartered in Salt Lake City, Utah, that the company has satisfied the criteria in the January 2007 consent decree required to resume operations. The OEC® 9900 Elite C-arm, a fluoroscopy device that uses x-rays to reveal real-time imagery of a patient's internal structure, is the first product to receive manufacturing and shipping authorization. More than 300 of these units will be shipped to customers in the first 10 days of operations.

"Above all, this is a great day for our customers," said Joe Hogan, President and CEO of GE Healthcare. "We'd like to thank the many hospitals that stood by and waited with us, believing in our product and our team. We can assure them, with the refinements we have made to our Surgery business' Quality Management System and the OEC 9900 C-arm, we have raised our own standards, creating a foundation that will serve our customers well into the future."

"Coming out of this, we're a better business," remarked Pete McCabe, President and CEO of GE Healthcare Surgery. "The OEC 9900 C-arm is the most reliable product produced in our business' 30-year history. Our quality system, alongside customer focus and technical innovations, is a foundation of our business. In the last year, we've been able to strengthen it to levels that will ensure we continue to differentiate our products and services as the best in the marketplace. We look forward to again being a leader in this highly competitive field."

Every day, seven out of ten surgeons rely on an OEC C-arm in their operating rooms. In fact, during GE Healthcare Surgery's stop-ship, many customers held their equipment orders, some waiting more than eighteen months. In a survey taken during the stop ship, more than 50% of prospective customers said they would buy an OEC C-arm if it were available. Responding to this overwhelming demand, GE Healthcare Surgery has added additional shifts and resources to work through its backlog as quickly as possible.

"It is extremely humbling to see customers stand by us and wait this out. It was the fuel that helped us focus, every day, to ensure we got it right. We plan to repay this overwhelming loyalty, and justify our customers' decisions to wait, with each system we ship," stated McCabe.

For More Information, History And Multimedia: http://www.Gehealthcare.Com/Oecshipping

About GE Healthcare

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.

GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries.

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