1. FDA

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    1. Mentioned In 358 Articles

    2. 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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    3. Conavi Medical Announces FDA 510(k) Clearance of the Novasight Hybrid System with Simultaneous Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) Capabilities

      Conavi Medical Announces FDA 510(k) Clearance of the Novasight Hybrid System with Simultaneous Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) Capabilities
      ...i.com) is pleased to announce that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its NovasightTM Hybrid System. The system enables simultaneous imaging of coronary arteries with both...
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    4. NinePoint Medical, Inc. Enters Into A Strategic Partnership and Worldwide Distribution with Merit Medical Systems, Inc.

      NinePoint Medical, Inc. Enters Into A Strategic Partnership and Worldwide Distribution with Merit Medical Systems, Inc.
      ...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 ...
      Read Full Article
    5. 3D mesoscopic fluorescence tomography for imaging micro-distribution of antibody-photon absorber conjugates during near infrared photoimmunotherapy in vivo

      3D mesoscopic fluorescence tomography for imaging micro-distribution of antibody-photon absorber conjugates during near infrared photoimmunotherapy in vivo
      As a novel low-side-effect cancer therapy, photo-immunotherapy (PIT) is based on conjugating monoclonal antibody (mAb) with a near-infrared (NIR) phthalocyanine dye IRDye700DX (IR 700). IR700 is not only fluorescent to be used as an imaging agent, but also phototoxic. When illuminating with NIR light, PIT can induce highly-selective cancer cell death while leaving most of tumor blood vessels unharmed, leading to an effect termed super-enhanced permeability and retention (SUPR), which ...
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    6. Multiple Research Scientist and Postdoctoral Positions in Computer Aided Diagnosis Department of Biomedical Engineering, Texas A&M University, College Station-Texas

      Multiple Research Scientist and Postdoctoral Positions in Computer Aided Diagnosis Department of Biomedical Engineering, Texas A&M University, College Station-Texas
      ...i>

      Additional exciting opportunities include:

      • Working closely with the FDA to develop a plan for filing 510(k) applications of the CAD systems for specific cancer detection clinical...
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    7. Multiple Research Scientist and Postdoctoral Positions in Endoscopic Instrumentation Department of Biomedical Engineering, Texas A&M University, College Station-Texas

      Multiple Research Scientist and Postdoctoral Positions in Endoscopic Instrumentation Department of Biomedical Engineering, Texas A&M University, College Station-Texas
      ...i>

      Additional exciting opportunities include:

      • Working closely with the FDA to develop a plan for filing 510(k) applications of the endoscopic tools for specific cancer detection cli...
      Read Full Article
    8. Optical coherence tomography angiography based biomarkers to assess the safety of peripheral nerve electrostimulation

      Optical coherence tomography angiography based biomarkers to assess the safety of peripheral nerve electrostimulation
      Peripheral nerves connect and relay information between the central nervous system and its target organs. Small arteries traverse the epineurium and are responsible for supplying blood to the axons and cells within the nerves. Constriction or damage to these vessels can reduce perfusion leading to ischemic insults. Peripheral nerve electrostimulation has been approved for the treatment of epilepsy, depression and migraines, and is also being studied for the treatment of ...
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    9. Method to investigate temporal dynamics of ganglion and other retinal cells in the living human eye

      Method to investigate temporal dynamics of ganglion and other retinal cells in the living human eye
      The inner retina is critical for visual processing, but much remains unknown about its neural circuitry and vulnerability to disease. A major bottleneck has been our inability to observe the structure and function of the cells composing these retinal layers in the living human eye. Here, we present a noninvasive method to observe both structural and functional information. Adaptive optics optical coherence tomography (AO-OCT) is used to resolve the inner ...
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    10. 1-15 of 358 1 2 3 4 ... 22 23 24 »
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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