1. FDA

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    1. Mentioned In 341 Articles

    2. Estimating Public and Patient Savings From Basic Research—A Study of Optical Coherence Tomography in Managing Antiangiogenic Therapy

      Estimating Public and Patient Savings From Basic Research—A Study of Optical Coherence Tomography in Managing Antiangiogenic Therapy
      ...14 , 15 , 16 There are 2 commonly used anti-VEGF drugs that are approved by the Food and Drug Administration (FDA) for this indication: ranibizumab (Lucentis; Genentech/Roche, South San Francisco, California, USA) and af...
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    3. Conavi Medical and China Grand Pharmaceutical and Healthcare Enter into Distribution Agreement for Minimally Invasive Imaging Technologies in China

      Conavi Medical and China Grand Pharmaceutical and Healthcare Enter into Distribution Agreement for Minimally Invasive Imaging Technologies in China
      ...omography (OCT) into a single catheter and platform. The Novasight Hybrid system has been submitted to the US FDA for 510(k) clearance. About Conavi Medical Inc. Conavi Medical Inc. is a privately-held commercial-stag...
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    4. New Clinical Data Presented at the World Congress of Gastroenterology @ ACG 2017 Shows Increased Dysplasia Detection Using Volumetric Laser Endomicroscopy with Laser Marking

      New Clinical Data Presented at the World Congress of Gastroenterology @ ACG 2017 Shows Increased Dysplasia Detection Using Volumetric Laser Endomicroscopy with Laser Marking
      ...s and more effective therapeutic options 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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    5. NinePoint Medical is featuring the NvisionVLE® Imaging System with Real-time Targeting™ at ACG 2017; Eight Scientific Abstracts to be Presented

      NinePoint Medical is featuring the NvisionVLE® Imaging System with Real-time Targeting™ at ACG 2017; Eight Scientific Abstracts to be Presented
      ...re effective therapeutic decisions for patients. Since the NvisionVLE® Imaging System has been cleared by the FDA, approximately 10,000 VLE procedures have been performed in the U.S. About NinePoint Medical, Inc. Nine...
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    6. University of Southern California Receives NIH Grant for Imaging Cerebral and Retinal Microvasculature in Cerebral Small Vessel Disease

      University of Southern California Receives NIH Grant  for Imaging Cerebral and Retinal Microvasculature in Cerebral Small Vessel Disease
      ...vascular imaging markers to readiness to enter into large-scale multi-site clinical validation studies toward FDA qualification for phase II and phase III clinical trials on small vessel disease to prevent and treat VCID...
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    7. Optovue First in US to Receive FDA Clearance for Corneal Epithelial Thickness Mapping New Mapping Technique May be Early Indicator of Ocular Health

      Optovue First in US to Receive FDA Clearance for Corneal Epithelial Thickness Mapping New Mapping Technique May be Early Indicator of Ocular Health
      .... Clinical Ophthalmology. 2009; 3:405-12. Optovue announced today that the U.S. Food and Drug Administration (FDA) has cleared the company’s epithelial thickness mapping software (epi-mapping) for quantitative measuremen...
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      Mentions: Optovue Jay Wei FDA
    8. Optical coherence tomography angiography: A comprehensive review of current methods and clinical applications

      Optical coherence tomography angiography: A comprehensive review of current methods and clinical applications
      ...ngiography (OCTA) is one such method that has rapidly gained clinical acceptance since it was approved by the FDA in late 2016. OCTA images are based on the variable backscattering of light from the vascular and neurosen...
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    9. 1-15 of 341 1 2 3 4 ... 21 22 23 »
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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