1. FDA

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    1. Mentioned In 426 Articles

    2. Perimeter Medical Imaging AI, Inc. Announces Stock Exchange Listing (TSX.V: PINK); Closing of Oversubscribed C$10m Private Placement Financing; Completion of Plan of Arrangement with New World

      Perimeter Medical Imaging AI, Inc. Announces Stock Exchange Listing (TSX.V: PINK); Closing of Oversubscribed C$10m Private Placement Financing; Completion of Plan of Arrangement with New World
      ...ists to visualize microscopic tissue structures during a clinical procedure. Perimeter's OTIS™ platform is an FDA-cleared point-of-care imaging system that provides clinicians with real-time, ultra-high-resolution, sub-s...
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    3. Characterization of New Optical Imaging Biomarkers of Peripheral Nerve Overstimulation

      Characterization of New Optical Imaging Biomarkers of Peripheral Nerve Overstimulation
      An animal study was designed to explore the potentially damaging effects of electrical overstimulation on peripheral nerves using a polarization‐sensitive optical coherence tomography (PS‐OCT) imaging and stimulation platform. Lewis rats (n = 15) were divided into 3 groups with 2 different levels of stimulation applied to the exposed sciatic nerve: Group 1 (sham control): 0.0 mA/0 Hz, Group 2: 3.4 mA/50 Hz, and Group 3 ...
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    4. Consolidation of Imaging Modalities Utilizing Digitally Assisted Visualization Systems: The Development of a Surgical Information Handling Cockpit

      Consolidation of Imaging Modalities Utilizing Digitally Assisted Visualization Systems: The Development of a Surgical Information Handling Cockpit
      ...ncept for the vitreoretinal operating room – a DAVS-based surgical information handling cockpit – integrating FDA approved ocular endoscopy (n=1), microscope-integrated iOCT units (n=3), and one EHR/Image management solu...
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    5. Conavi Medical and Japan Lifeline Announce MHLW Approval of Novasight Hybrid Intravascular Imaging System for Japanese Market

      Conavi Medical and Japan Lifeline Announce MHLW Approval of Novasight Hybrid Intravascular Imaging System for Japanese Market
      ...tical coherence tomography (OCT) on a single imaging catheter. The system also has Health Canada approval and FDA 510(k) clearance in the USA. Japan Lifeline is the exclusive distributor for this technology in Japan. Dr...
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    6. AI-based retinal fluid analytics of serial Notal Vision home OCT images offers insights into retinal disease dynamics

      AI-based retinal fluid analytics of serial Notal Vision home OCT images offers insights into retinal disease dynamics
      ...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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    7. 1-15 of 426 1 2 3 4 ... 27 28 29 »
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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