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FDA OKs Study for Wireless CRT Pacing Leads

[ Price : $8.95]

FDA grants EBR Systems an Investigational Device Exemption for its WiSE (Wireless Stimulation Endocardially) technology for cardia...

Guidance on Using Nucleic Acid Tests for West Nile Testing

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Federal Register notice: FDA releases a guidance on Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Viru...

FDA OKs Carl Zeiss PMA for VisuMax Laser

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FDA approves a Carl Zeiss Meditec PMA for the VisuMax Femtosecond Laser for the small incision lenticule extraction procedure to r...

FDA Says Harrington House Selling Unapproved Drugs

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FDA warns Harrington House that its Web site is selling unapproved new drugs.

Former J&J Rep Convicted of Medical Device Conspiracy

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Former J&J medical device sales representative Kerri Kaley is convicted of conspiracy to fraudulently obtain and transport medical...

FDA Wants Antimicrobials Input

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FDA asks for public input on three questions involving duration of use of key human antimicrobials also used in animal food and wa...

Guidance on Plasma Fibrinogen Biomarker Qualification

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Federal Register notice: FDA posts a guidance on Qualification of Biomarker Plasma Fibrinogen in Studies Examining Exacerbations ...

CDER Plans New Guidances on Combos, Quality Metrics

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CDER says it will develop a guidance this year on Comparative Analyses of the Device Constituent of a Drug-Device Combination Prod...

FDA Guidance on Cell/Tissue Donor Testing

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FDA posts a guidance on Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Huma...

Novocure Reports Favorable Long-term Data with Optune System

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Novocure says a long-term survival analysis of data from a Phase 3 (EF-14) trial of Optune in combination with temozolomide confir...