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Search Results “food and drug administration”  

British Surgeons Pioneer Endovascular Surgery With Hansen Medical's Magellan(TM) Robotic System

Investor Contacts:
Peter J. Mariani
Chief Financial Officer
Hansen Medical, Inc.
650.404.5800

FTI Consulting, Inc.
Sharrifah Al-Salem, CFA
415.293.4414
Email Contact

John Capodanno
212.850.5705
Email Contact

Unprecedented International Effort Seeks to Improve Safety of Orthopedic Devices

NEW YORK, Dec. 21, 2011 /PRNewswire/ -- Responding to a need for better post-market surveillance of orthopedic devices, the U.S. Food and Drug Administration established the International Consortium of Orthopaedic Registries in October 2010. As outlined in a Dec. 21 special...

SpectraFluidics Inc. Receives $1.3M Award from Transportation Security Administration

SANTA BARBARA, Calif., Dec. 14, 2011  /PRNewswire/ -- SpectraFluidics Inc., a company that specializes in developing and manufacturing trace vapor chemical detection and analysis technology, was recently awarded a $1.3 million contract from the U.S. Department of Homeland Security,...

Australia's SA Health Finalizes Allscripts Agreement

CHICAGO and ADELAIDE, Australia, Dec. 13, 2011 /PRNewswire/ -- SA Health, the public health system of South Australia, announced in a press conference today in Adelaide that it signed the final agreement to deploy the Sunrise Enterprise™ suite of advanced...

FDA News & Notes - Week of December 5, 2011

SILVER SPRING, Md., Dec. 5, 2011 /PRNewswire-USNewswire/ -- Science, public health, and regulatory highlights from the U.S. Food and Drug Administration. Information in this document is designed for credentialed journalists. Release dates and times for items are current as of...

New Study Finds High Magnesium Intake Helps Reduce Fear and Anxiety

LOS ANGELES, Dec. 5, 2011 /PRNewswire/ -- A supplemented intake of magnesium is found to enhance the brain's ability to reduce fear and anxiety responses, making way for a possible supplemental treatment for many anxiety disorders such as social anxiety...

MedinCell to Explore Controlled-Release Drug Delivery Partnerships at the World Animal Health Congress

SAN DIEGO and MONTPELLIER, France, Dec. 2, 2011 /PRNewswire/ -- MedinCell, a leading developer of low-cost, controlled-release drug delivery technology, will be exploring partnerships for key companion and food animal markets with industry leaders at the Terrapinn World Animal Health...

Empowered Products Announces Increased Efficiency on Production of PINK® and GunOil® Libido-Enhancement Supplements

LAS VEGAS, Dec. 2, 2011  /PRNewswire/ -- Empowered Products, Inc. (OTCBB: EMPO) is pleased to report increased efficiency on blister pack production via its newly purchased Starview Blister Sealer machine. The machine is currently being utilized onsite at the...

Neo Dental's Cavios Cavity Liner, Evadyne Temporary Resin Cleared by FDA for Sale in US

Firm obtains FDA 510(k) clearances with assistance from Emergo Group.

Neo Dental's Cavios Cavity Liner, Evadyne Temporary Resin Cleared by FDA for Sale in US

Firm obtains FDA 510(k) clearances with assistance from Emergo Group.
GSK signs agreement with Impax for Parkinson’s drug ​

GSK signs agreement with Impax for Parkinson's drug

The UK's largest drug maker, GlaxoSmithKline, has signed an agreement with Impax Pharmaceuticals for development and commercialisation rights to Impax's Parkinson's combination drug IPX066. Impax says IPX066 has the potential to control Parkinson’s symptoms, such as the reduction in “off time” throughout the day.
FDA Rejects Vivus’ Weight Loss Drug Qnexa ​

FDA Rejects Vivus’ Weight Loss Drug Qnexa

Qnexa has been described by many experts as the most promising weight loss drug in more than a decade. Studies have shown that on average, patients using the drug lost more than 10 percent total body mass. This is in comparison to other weight loss pills currently on the market, like Roche’s Xenical where patients have recorded a weight loss of under 5 percent.
Johnson & Johnson Produces Real Shards o' Glass Product ​

Johnson & Johnson Produces Real Shards o' Glass Product

 
MS Patients Get New Oral Treatment Approved ​

MS Patients Get New Oral Treatment Approved

 
U.S drug regulator: Warns Sun Pharma ​

U.S drug regulator: Warns Sun Pharma

The United States Food and Drug Administration (USFDA) has issued a warning letter to Sun Pharmaceuticals as the company was found violating manufacturing norms in its Cranbury facility in New Jersey. Sun Pharma has stated that the FDA has withheld approval of pending new drug applications listing the facility as the manufacturer.
H1N1 Flu Test Kit authorized by FDA for use by CLIA high-complexity labs ​

H1N1 Flu Test Kit authorized by FDA for use by CLIA high-complexity labs

Focus Diagnostics has announced that its Influenza A H1N1 (2009) Real Time RT-PCR test is available as a test kit for use by "high complexity" clinical laboratories in the U.S.
NAM urges U.S.-China cooperation on safe imports ​

NAM urges U.S.-China cooperation on safe imports

The National Association of Manufacturers (NAM) has told Congress that the safety of Chinese imports are of the utmost concern to America's manufacturers and consumers.
NAM concern with Chinese imports situation ​

NAM concern with Chinese imports situation

"The situation demands action on China's part and, as necessary, pressure from the United States to prompt that action," Jay Timmons, the NAM's senior vice president of policy and government relations

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