1. FDA

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    1. Mentioned In 322 Articles

    2. Methods to assess sensitivity of optical coherence tomography systems

      Methods to assess sensitivity of optical coherence tomography systems
      Measuring the sensitivity of an optical coherence tomography (OCT) system determines the minimum sample reflectivity it can detect and provides a figure of merit for system optimization and comparison. The published literature lacks a detailed description of OCT sensitivity measurement procedures. Here we describe a commonly-used measurement method and introduce two new phantom-based methods, which also offer a means to directly visualize low reflectivity conditions relevant to biological tissue. We ...
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    3. Avinger Announces New FDA Clearance for Lumivascular Imaging Console, Enabling Vessel Measurement Via Touchscreen

      Avinger Announces New FDA Clearance for Lumivascular Imaging Console, Enabling Vessel Measurement Via Touchscreen
      ...ay announced that the company has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Lightbox L250 imaging console. With this new FDA clearance, the Lightbox L250 now provides detail...
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    4. Feasibility study: protein denaturation and coagulation monitoring with speckle variance optical coherence tomography

      Feasibility study: protein denaturation and coagulation monitoring with speckle variance optical coherence tomography
      We performed the feasibility study using speckle variance optical coherence tomography (SvOCT) to monitor the thermally induced protein denaturation and coagulation process as a function of temperature and depth. SvOCT provided the depth-resolved image of protein denaturation and coagulation with microscale resolution. This study was conducted using egg white. During the heating process, as the temperature increased, increases in the speckle variance signal was observed as the egg white proteins ...
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    5. NinePoint Medical Announces Substantial Hospital Reimbursement Increase for Procedures Using the NvisionVLE Imaging System with Real-time Targeting

      NinePoint Medical Announces Substantial Hospital Reimbursement Increase for Procedures Using the NvisionVLE Imaging System with Real-time Targeting
      ...ore effective therapeutic decisions for patients.   The NvisionVLE Imaging System has been cleared by the FDA and is commercially available in the U.S. It is indicated for use as an imaging tool in the evaluation of ...
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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