1. FDA

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    1. Mentioned In 370 Articles

    2. NinePoint Medical Announces FDA Clearance of an Artificial Intelligence Software Upgrade for the NvisionVLE Imaging System

      NinePoint Medical Announces FDA Clearance of an Artificial Intelligence Software Upgrade for the NvisionVLE Imaging System
      ...rm for gastrointestinal applications, announced today that it has received U.S. Food and Drug Administration (FDA) clearance to market its Intelligent Real-time Image Segmentation™ (IRIS) software upgrade for its flagshi...
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    3. Conavi Medical and Japan Lifeline Advance Japanese Sales Strategy of Novasight Hybrid Intravascular Imaging System

      Conavi Medical and Japan Lifeline Advance Japanese Sales Strategy of Novasight Hybrid Intravascular Imaging System
      ...erence tomography (OCT) on a single imaging catheter. Earlier this year, the Novasight Hybrid system received FDA 510(k) clearance in the United States and was featured by Conavi Medical at the TCT 2018 Interventional Ca...
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    4. Optovue Showcases World’s First OCT Angiography Metrics and Non-contact Method for Corneal Measurements at Vision Expo West

      Optovue Showcases World’s First OCT Angiography Metrics and Non-contact Method for Corneal Measurements at Vision Expo West
      ... style="text-align: justify;">Optovue recently received FDA 510(k) clearance for AngioAnalytics, and expanded FDA clearance for ETM, which added the nine-millimeter ETM scan to the previously available six-millimeter map...
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      Mentions: Optovue Jay Wei FDA
    5. Avinger Completes Enrollment in SCAN Clinical Study Comparings OCT Imaging with IVUS for Diagnostic Imaging in Peripheral Arteries

      Avinger Completes Enrollment in SCAN Clinical Study Comparings OCT Imaging with IVUS for Diagnostic Imaging in Peripheral Arteries
      ...ation, and has a resolution approximately ten times greater than IVUS. The U.S. Food and Drug Administration (FDA) has cleared both diagnostic and therapeutic treatment indications for use for Avinger’s Pantheris (athere...
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      Mentions: FDA Avinger
    6. NinePoint Medical Appoints Eman Namati, Ph.D., to Chief Executive Officer

      NinePoint Medical Appoints Eman Namati, Ph.D., to Chief Executive Officer
      ...and more 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