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New Critical Path Report Highlights Research Needed to Foster Generic Drug Development

The report is part of FDA's Critical Path Initiative, established in 2004 to discern what challenges exist in moving a promising drug, biologic or device along the critical path from discovery, or proof of concept, to a marketable product
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01626.html

FDA Requests Recall of All Shelhigh Medical Devices

at FDA's request, seized all medical devices including components at Shelhigh's Union, N.J. facility after finding significant deficiencies in the company's manufacturing processes.
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01625.html

FDA Announces Recommendations to Reauthorize Medical Device User Fee Program

...which, if adopted, would help to ensure that safe and effective medical devices get to patients in a timely manner.
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01609.html

FDA Provides Web Access to Information on Post-Approval Device Studies

Modern devices provide significant health benefits, but experience has shown that the full magnitude of some potential risks doesn't always emerge during the mandatory clinical trials that are required for approval
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01603.html

Latebreakers: DMEPOS Web site goes live

Durable medical equiment, prosthetics, orthotics, and supplies bidding site
http://www.drugtopics.com/drugtopics/article/articleDetail.jsp?id=415065

New Technology Heralds Hope

Breakthrough therapies and technologies provide the tools to improve muscle disorders with gait and balance training.
http://www.rehabpub.com/issues/articles/2007-04_02.asp

Not a Lightweight Decision

Selecting an ultralight wheelchair: Six common mistakes, and how to fix them
http://www.rehabpub.com/issues/articles/2007-04_04.asp

Yearly breast MRIs urged for 1.4 million women

New cancer guidelines advise pricey screening for those at high risk
http://www.msnbc.msn.com/id/17818068/

Medical Devices 101: An Educational Forum; Public Workshop

This public workshop is intended to provide an overview on FDA's medical device requirements to entrepreneurs, startup companies, and small businesses.
http://www.fda.gov/OHRMS/DOCKETS/98fr/07-92.htm

CMS names 11 accreditors for DMEPOS suppliers

The Centers for Medicare & Medicaid Services recently selected 11 national organizations to accredit suppliers of durable medical equipment, prosthetics, orthotics, and supplies...
http://www.drugtopics.com/drugtopics/article/articleDetail.jsp?id=394814
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