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The Medical Industry
Business Weekly
May 08, 2008

Other Headlines

DOTmed was first to break the news late last week that GE's OEC division was given the green light to re-start production; GE says more than 300 OEC® 9900 Elite C-arms are slated to ship within the first 10 days as they start to fill back-orders.
Quinn 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.

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More Industry Headlines

OEC Re-Certified by FDA -- Latest Update DOTmed was first to break the news late last week that GE's OEC division was given the green light to re-start production; GE says more than 300 OEC® 9900 Elite C-arms are slated to ship within the first 10 days as they start to fill back-orders.

SNM 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.

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.

Food and Drug
Administration

Legislative Work Continues on Revamping FDA

by Astrid Fiano, Writer
Senate legislators are targeting improvements for the Food and Drug Administration. A bipartisan group has recommended that the FDA receive more funding after listening to testimony during a Senate Appropriations subcommittee hearing this month. Sen. Herb Kohl (D-WI) said the agency was "seriously underfunded," according to a recent New York Times article. In testimony to the subcommittee, FDA Commissioner Andrew C. von Eschenbach, M.D., discussed the agency's budget request and the stressed the need to modernize the FDA's workforce and infrastructure.

In the House, Energy and Commerce Committee Chair John Dingell (D-Mich.) has new legislation proposed for increased FDA funds and regulatory changes. During a Senate subcommittee on health for the Committee on Oversight and Commerce hearing last week, Rep. Dingell told the committee members that the FDA is "starved" for resources. Rep. Dingell's proposals are in The Discussion Draft Food and Drug Administration Globalization Act. The Act builds upon previous House bills and results from subcommittee investigations, and has changes to current FDA law including: an annual registration fee for domestic and foreign drug and device establishments; a requirement for domestic and foreign drug and device establishments to be inspected every 2 years; giving the Secretary of Health and Human Services the same recall authority with respect to drugs as the Secretary has with respect to devices; and a requirement for importers of food, drugs, devices, and cosmetics to register with the Secretary and to pay an annual registration fee of $10,000.

The FDA itself has previously stressed to Congress this year that it needs considerably more funding. Janet Woodcock, deputy commissioner for scientific affairs and chief medical officer, testified in February to the House Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies concerning budgetary needs for import investigations and better prescription drug-tracking. Shortly thereafter, in light of concerns over the Heparin problems, Congresswoman Rosa L. DeLauro (D-CT) called for a larger FDA budget of $145 million over 2007 funding, but also for less influence on the agency from drug companies and better management.

More information:
http://appropriations.senate.gov/hearings.cfm?s=arg
http://www.house.gov/delauro/
http://www.dotmed.com/news/story/5424/

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