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July 31, 2008

GE Sees ‘Quality Dividend’ From FDA Consent Decree


Remediation efforts result in more efficient manufacturing

July 29, 2008

Theragenics Completes Acquisition of NeedleTech Products


Specialty Needle Manufacturer Continues to Diversify Theragenics Business

July 28, 2008

FDA Cites Cardinal for Sharps Containers


Company allegedly did not evaluate or investigate four complaints about needle sticks

GE to Acquire Vital Signs for $860 Million Cash


Move will expand GE's $17 billion health care operation into the single-use products market

July 24, 2008

Zimmer To Suspend Sales of Artificial Hip Device


Doctors complained device was failing at a high rate

FDA Warns Anika Therapeutics on Problems at Manufacturing Plant


Problems uncovered during March inspection

July 23, 2008

FDA to Establish Offices in India by 2009


Move is part of FDA effort to improve monitoring of imported products

Electronic Quality Systems Can Reduce Cost of Recalls


“Closed-loop system” could reduce a manufacturer’s exposure

July 22, 2008

Theragenics to Acquire NeedleTech


Deal worth $47.8 million

FDA Official Claims Center for Devices and Radiological Health Is Losing Device Expertise


Ability to better identify problems requires substantial resources

July 21, 2008

Zimmer Recalls Knee-Surgery Instrument


Recall follows reports that equipment broke during surgery

FDA Plans to Release ISO Audit Guidance


Guidance will explain how FDA will interpret International Organization for Standardization audit reports

July 14, 2008

AngioDynamics Initiates Voluntary Recall of Its Centros Catheter


Company discovers catheter was inadequately attached in several cases

New Legislation Introduced to Override Landmark Supreme Court Decision on Medical Devices


Bill removes barriers to plaintiffs initiating private lawsuits against manufacturers

July 11, 2008

Moody's: Enhanced FDA Scrutiny Could Pressure Device Makers


Johnson & Johnson, Boston Scientific appear to be most vulnerable to the increased scrutiny