1. FDA

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    1. Mentioned In 452 Articles

    2. Asclepix Therapeutics partners with Notal Vision on Home OCT remote monitoring in DME and AMD clinical trials

      Asclepix Therapeutics partners with Notal Vision on Home OCT remote monitoring in DME and AMD clinical trials
      ...echnology received FDA Breakthrough Device designation at the end of 2018, and is in the process of obtaining FDA clearance. In January 2020 the American Medical Association established three category III Current Procedu...
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    3. Label-free adaptive optics imaging of human retinal macrophage distribution and dynamics

      Label-free adaptive optics imaging of human retinal macrophage distribution and dynamics
      Microglia are resident central nervous system macrophages and the first responders to neural injury. Until recently, microglia have been studied only in animal models with exogenous or transgenic labeling. While these studies provided a wealth of information on the delicate balance between neuroprotection and neurotoxicity within which these cells operate, extrapolation to human immune function has remained an open question. Here we examine key characteristics of retinal macrophage cells in ...
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    4. MediciNova Announces Positive Optical Coherence Tomography Results from the SPRINT-MS Phase 2b Trial of MN-166 (ibudilast) in Progressive MS Published in Multiple Sclerosis Journal

      MediciNova Announces Positive Optical Coherence Tomography Results from the SPRINT-MS Phase 2b Trial of MN-166 (ibudilast) in Progressive MS Published in Multiple Sclerosis Journal
      ...als, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and comme...
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    5. Acute Bilateral Uveitis, Hypotony, and Cataracts Associated with Ipilimumab and Nivolumab Therapy: Optical Coherence Tomography Angiography Findings

      Acute Bilateral Uveitis, Hypotony, and Cataracts Associated with Ipilimumab and Nivolumab Therapy: Optical Coherence Tomography Angiography Findings
      ...ion and enhancement of the immune response against tumor cells. Since 2011, the Food and Drug Administration (FDA) has approved a number of ICI therapies, including immunoglobulin G1 (IgG1) anti-CTLA-4 human monoclonal a...
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    6. Direct laser writing of a titanium dioxide-laden retinal cone phantom for adaptive optics-optical coherence tomography

      Direct laser writing of a titanium dioxide-laden retinal cone phantom for adaptive optics-optical coherence tomography
      The spatial resolution of adaptive optics-optical coherence tomography (AO-OCT) enables visualization of retinal components ( e.g ., photoreceptors), which can advance clinical diagnosis of ocular diseases. Currently, however, variability in AO-OCT system performance suggests a need for standardized physical models, or phantoms, that replicate the opto-structural properties of retinal components. Here we employ direct laser writing a two-photon polymerization-based additive manufacturing technology using a light scattering titanium (IV) dioxide nanoparticle-laden photomaterial ...
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    7. 1-15 of 452 1 2 3 4 ... 28 29 30 »
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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