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510(k) Final Decisions - November 2010(2)

December 9, 2010 8:31 am | by U.S. Food & Drug Administration | Comments

Page Last Updated: 12/09/2010 Note: If you need help accessing information in different file formats, see Instructions for Downlo

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510(k) Final Decisions - November 2010

December 9, 2010 8:30 am | Comments

Page Last Updated: 12/09/2010 Note: If you need help accessing information in different file formats, see Instructions for Downlo

Centric Health buys surgical centre operator Surgical Spaces for $24 million

December 9, 2010 7:45 am | by The Associated Press | Comments

Centric Health Corp. (TSX:CHH) to buy Surgical Spaces Inc., operator of False Creek Surgical Centre in Vancouver and Maples Surgical Centre in Winnipeg, for $24 million in cash-and-shares deal.

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On Semiconductor low profile CSP for mobile products

December 9, 2010 7:35 am | by I-Micronews | Comments

Supplying the smart phone marketplace is requiring components to become thinner and thinner. Umesh Sharma of On Semiconductor indicates that ??In thin smart phone products, the space between the cable and the board is so small that only ultra-thin IC or discrete components could be placed...

European photonics business roundtable launched

December 9, 2010 7:35 am | by I-Micronews | Comments

To create business relationships between photonics SMEs (small and medium enterprises) and technology integrators, a group of European defense integrators and photonics clusters have launched a business roundtable for photonics sensors for defense and security.

Breakthrough towards lab-on-chip system for fast detection of single nucleotide variations in DNA

December 9, 2010 7:35 am | by I-Micronews | Comments

Panasonic, core partner within imec?s Human++ program, and imec today presented at the International Electron Devices Meeting in San Francisco various critical components of a biomedical lab-on-chip sensor enabling fast detection of Single Nucleotide Polymorphisms (SNPs) in DNA, such as a...

Caliper buying optical imaging play CRi for $20M

December 9, 2010 7:34 am | by Mass High Tech: The Journal of New England Technology | Comments

Caliper Life Sciences Inc. is paying $20 million to acquire Cambridge Research & Instrumentation Inc. (CRi), a developer of optical imaging systems. Caliper plans to consolidate and move CRi's operations from Woburn to Caliper's headquarters in Hopkinton.

CDRH FY 2010 Strategic Priorities - Accomplishments

December 9, 2010 7:34 am | by U.S. Food & Drug Administration | Comments

In January we released to the public and began implementing our 2010 strategic plan. The plan, CDRH FY 2010 Strategic Priorities, identified four priority areas of activity that presented significant opportunities to improve our effectiveness in...

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Analyzing the Unborn Genome

December 9, 2010 7:34 am | by Massachusetts Institute of Technology | Comments

Mapping the genome of a fetus from its mother's blood could mean less risky screening for prenatal diseases.

Sanofi-aventis Oncology Data to be Presented at San Antonio Breast Cancer Symposium

December 9, 2010 7:34 am | by Bio-Medicine.Org | Comments

BRIDGEWATER, N.J., Dec. 9, 2010 /- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY ) announced today that the final survival analysis (10-year follow-up) of the BCIRG001 study that included a Taxotere® (docetaxel) Injection Concentrate chemotherapy treatment regimen in the adjuvant...

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Ambry Genetics Launches Illumina HiSeq 2000 Next Generation Sequencing Services

December 9, 2010 7:33 am | by Bio-Medicine.Org | Comments

ALISO VIEJO, Calif., Dec. 9, 2010 /- Ambry Genetics, a global leader in genomic services to the healthcare and life sciences industries, announced today that it has officially launched their Illumina HiSeq 2000 Next Generation Sequencing Services. Ambry Genetics has been an early adapter...

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Caliper Life Sciences to Acquire Cambridge Research & Instrumentation

December 9, 2010 7:33 am | by Bio-Medicine.Org | Comments

HOPKINTON and WOBURN, Mass., Dec. 9, 2010 /- Caliper Life Sciences, Inc. (Nasdaq: CALP ), a leading provider of products and services for drug discovery research, today announced that it has entered into a definitive agreement to acquire privately-held Cambridge Research &...

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Study Shows Novartis Drug Afinitor® Plus Hormonal Therapy Delays Disease Progression in Advanced Metastatic Breast Cancer Patients

December 9, 2010 7:33 am | by Bio-Medicine.Org | Comments

EAST HANOVER, N.J., Dec. 9, 2010 /- A new study shows that the addition of everolimus (Afinitor® tablets) to the hormonal therapy tamoxifen in patients with hormone-receptor positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer who have been...

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Anthera Announces Update Call Regarding Vial Problems

December 9, 2010 7:32 am | by Bio-Medicine.Org | Comments

HAYWARD, Calif., Dec. 9, 2010 /- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH ), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced it will hold a conference call to provide an update on the ongoing investigation and...

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HeartWare plans to sell $100M in senior notes

December 9, 2010 6:45 am | by The Associated Press | Comments

Heart device maker HeartWare International Inc. said Thursday it plans to sell $100 million in senior notes due in 2016, and disclosed that its biggest shareholder is selling part of its stake in the company.The news sent shares sliding $6.04, or 6.8 percent, to $82.86 in morning...

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