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The Medical Industry Business Weekly |
| May 08, 2008 |
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Other HeadlinesQuinn succeeds Jim Reid-Anderson, who has been named new CEO of Siemens Healthcare.
Account rep Grant Norris is DOTmed Certified.
Normally, three's a crowd. But the trifecta of OEMs, refurbishers and broker/dealers is the engine that's driving the medical trailer business.
Online marketplace for new and used medical equipment reaches another milestone.
The Society of Nuclear Medicine -- SNM -- holds its Annual Meeting this June 14-18 in New Orleans, LA.
Exhibitors: You can still get a booth if you hurry!
Have News for Us?Submit your news on the industry, people, or companies.More Industry HeadlinesSNM Annual Meeting Just About a Month Away The Society of Nuclear Medicine -- SNM -- holds its Annual Meeting this June 14-18 in New Orleans, LA. Exhibitors: You can still get a booth if you hurry! Medicare Expands Coverage for Artificial Heart Devices Decision opens access to advanced technology. GE Healthcare Introduces New 3.0T MR Scanner Breakthrough technology with simple design provides radiologists with powerful applications for increased clinical capability. Get Your Bid in Now on This GE Signa MR/i Hispeed Plus MRI Scanner -- Just Posted on DOTmed! Also see the other great lasers, imaging systems, and more... all on your favorite website for used medical equipment! Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators. Legislative Work Continues on Revamping FDA Congress, Agency say more funding is needed to improve safety. Healthcare Experts to Address Medical Technology Executives at Annual Conference Medical device industry leaders and key healthcare subject matter experts will meet in Washington, DC for the 2008 Annual Meeting of the Medical Device Manufacturers Association (MDMA). Cosmetic Soft-Tissue Filler Injections Linked to Cases of Acute Renal Failure Investigation finds adverse effects from non-medically supervised procedures. Wolters Kluwer Health & Johns Hopkins Launch The Patient First journal dedicated to using scientific methods for patient-centric research. Speaker to Explore Amazing Future of Biotechnology at AAMI Conference Joint Commission executive to provide up-to-date guidance at Association for the Advancement of Medical Instrumentation meeting May 31-June 2 in San Jose, CA. 
OEC was given the
green light to re-start production at the end of last week. OEC Re-Certified by FDA -- Latest Updateby Robert Garment, Director of Marketing
Last Friday, May 2nd, DOTmed Online News was the first news organization to break the story that GE's OEC division (which is part of GE Healthcare Surgery) received notification from the U.S. Food and Drug Administration (FDA) that OEC has met the requirements under the January 2007 consent decree to resume regular production.
GE further told DOTmed at that time that OEC could not ship until the FDA approved their 510(k) request for pre-market clearance. GE received that OK this Monday, May 5th. The first product out the door will be the 9900 Elite C-arm. OEC expects to ship 300 by mid-May, and then ship 50 units a week for the foreseeable future until their backlog of orders is filled. "This is a great day for our customers," observed Joe Hogan, President and CEO of GE Healthcare. "We'd like to thank the thousands of 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. "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." OEC asserts that it has improved its manufacturing quality assurance program, and that the new 9900s coming out of their Salt Lake City facility are "the best quality C-arms GE/OEC has ever made," according to Pete McCabe. For GE's OEC website go here: OEC Shipping. Please Send us your Comments. |
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