1. FDA

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    1. Mentioned In 251 Articles

    2. Michelson Diagnostics closes £2.5 million First Tranche of £4.0 million Series B fundraising Smith & Nephew as Cornerstone Investor

      Michelson Diagnostics closes £2.5 million First Tranche of £4.0 million Series B fundraising Smith & Nephew as Cornerstone Investor
      ...of-care, real-time tissue imaging device.  The patented technology, which has CE/TGA regulatory-clearance and FDA 510(k) approval in the United States, provides clinicians with continuous images of the epidermis and supe...
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    3. Bausch + Lomb Introduces New Software and Advanced OCT Imaging System for VICTUS® Femtosecond Laser Platform

      Bausch + Lomb Introduces New Software and Advanced OCT Imaging System for VICTUS® Femtosecond Laser Platform
      ...ly owned subsidiary, Bausch + Lomb, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an advanced Swept Source OCT (Optical Coherence Tomography) imaging system and updated software for i...
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    4. Bioptigen Awarded $458,000 from North Carolina Biotechnology Center to Advance Intrasurgical OCT System Development

      Bioptigen Awarded $458,000 from North Carolina Biotechnology Center to Advance Intrasurgical OCT System Development
      ...investigational device, limited by United States law to investigational use. The device is not cleared by the FDA to be marketed, sold, or distributed within the United States. Bioptigen Inc. is an innovative medical t...
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    5. Feature Of The Week 11/2/14: Longitudinal Vascular Dynamics Following Cranial Window and Electrode Implantation Measured with Speckle Variance Optical Coherence Angiography

      Feature Of The Week 11/2/14: Longitudinal Vascular Dynamics Following Cranial Window and Electrode Implantation Measured with Speckle Variance Optical Coherence Angiography
      ...oe/abstract.cfm?URI=boe-5-8-2823. For more information see recent Article . Courtesy Daniel Hammer from FDA . FDA researchers Daniel X. Hammer, Andrea Lozzi, Erkinay Abliz, Noah Greenbaum, Anant Agrawal, Victor Krauthame...
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    6. Feature Of The Week 8/31/14: Fully Integrated High-speed Intravascular OCT/NIRF Structural/Molecular Imaging In Vivo using a Clinically-available NIRF Emitting Indocyanine Green to Detect Inflamed Lipid-rich Atheromata in Coronary-sized Vessels

      Feature Of The Week 8/31/14: Fully Integrated High-speed Intravascular OCT/NIRF Structural/Molecular Imaging In Vivo using a Clinically-available NIRF Emitting Indocyanine Green to Detect Inflamed Lipid-rich Atheromata in Coronary-sized Vessels
      ...ic rotary junction (FRJ) design, 3) use indocyanine green (ICG) as a NIRF signal enhancing agent, which is an FDA-approved NIRF emitting agent clinically approved for fluorescence angiogram of humans in ophthalmologic an...
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    7. 1-15 of 251 1 2 3 4 ... 15 16 17 »
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  2. About FDA

    FDA

    U.S. Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on products ranging from pet turtles to semen donations for assisted reproductive medicine techniques.

  3. Quotes about FDA

    1. LightLab has been delivering state-of-the art intracoronary OCT systems to leading hospitals outside of the United States for over 5 years...With our clearance by the FDA, U.S. clinicians now have access to a fast and easy-to-use, high-resolution imaging system. We believe C7-XR Imaging System and C7 Dragonfly Imaging Catheter will enhance the diagnostic information and procedural control available to U.S clinicians. We will begin offering the C7-XR Imaging System and the C7 Dragonfly Imaging Catheter immediately.
      David W. Kolstad in LightLab Imaging Announces FDA Clearance of C7-XR™ Coronary OCT Products in the United States
    2. One year after the launch of our C7-XR system at PCR, the results throughout Europe have been outstanding...This has been a tremendous year for LightLab OCT both in Europe and in the United States, with the achievement of our FDA clearance and US introduction earlier this month. We are pleased with our progress toward LightLab OCT becoming the worldwide intracoronary imaging gold-standard.
      David W. Kolstad in LightLab Imaging Returns to EuroPCR 2010 With Strong and Growing Worldwide Acceptance of C7-XR OCT Imaging System
    3. Following our 19% revenue growth in 2009 over 2008, we expected the economy and other market factors to dampen or hold our revenue growth to last year's levels...However, a significant order rate increase from December 2009 into -- and throughout -- our first quarter in 2010 surpassed our expectations for both the top line revenue and gross profits. With the FDA clearance of the iVue compact OCT system in April, we are continuing through Q2 and with significant top line growth momentum that we expect to continue through the remainder of this year.
      Gordon Wong in Optovue Q1 2010 Revenue Up 57% Over Same Quarter 2009