1. FDA

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    1. Mentioned In 241 Articles

    2. 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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    3. Fully Integrated High-Speed Intravascular OCT/NIRF Structural/Molecular Imaging In Vivo Using a Clinically Available Near-Infrared Fluorescence–Emitting Indocyanine Green to Detect Inflamed Lipid-Rich Atheromata in Coronary-Sized Vessels

      Fully Integrated High-Speed Intravascular OCT/NIRF Structural/Molecular Imaging In Vivo Using a Clinically Available Near-Infrared Fluorescence–Emitting Indocyanine Green to Detect Inflamed Lipid-Rich Atheromata in Coronary-Sized Vessels
      ...roborated the in vivo imaging findings. Conclusions—Integrated OCT/NIRF structural/molecular imaging with a Food and Drug Administration –approved ICG accurately identified lipid-rich inflamed atheromata in coronary-si...
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    4. Quantitative analysis of low contrast detectability in optical coherence tomography

      Quantitative analysis of low contrast detectability in optical coherence tomography

      Optical coherence tomography (OCT) is a high resolution imaging technology that is rapidly being adopted as the standard of care for medical applications such as ocular and intravascular imaging. However, clinical translation has been hampered by the lack of standardized test methods for performance evaluation as well as consensus standards analogous to those that have been developed for established medical imaging modalities (e.g., ultrasound). In this study, we address low contrast detectability, specifically, the ability of systems to differentiate between regions exhibiting small differences in scattering coefficient. Based on standard test methods for established medical imaging modalities, we have ...

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    5. Optical frequency domain imaging in patients with Barrett's neoplasia: an ex vivo case study with correlated endoscopic and histology views

      Optical frequency domain imaging in patients with Barrett's neoplasia: an ex vivo case study with correlated endoscopic and histology views

      This video (, available online at www.giejournal.org) describes the optical frequency domain interferometry (OFDI) imaging technique, which is a U.S. Food and Drug Administration–approved and commercially available second-generation of optical coherence tomography, and its close correlation with endoscopic views and histopathology results in patients with Barrett's esophagus.

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      Mentions: FDA
    6. International Workshop on Tissue Phantoms and Standardization in Biophotonics at University of Maryland, May 21, 2014

      International Workshop on Tissue Phantoms and Standardization in Biophotonics at University of Maryland, May 21, 2014
      ... Ogden, General Surgery Devices Branch Chief, FDA Bradley Cunningham, Diagnostic and Surgical Devices Branch, FDA Joshua Pfefer, FDA Brian Pogue, Dartmouth College Albert Cerussi, UC Irvine Jessica Romella-Roman, Florida...
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    7. 1-15 of 241 1 2 3 4 ... 14 15 16 »
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  2. About FDA

    FDA

    The 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