1. FDA

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    1. Mentioned In 306 Articles

    2. OCT Medical Imaging Inc. Receives a NIH Grant for Clinical Evaluation and Development of a Diagnostic Multi-modal Intravascular Imaging System

      OCT Medical Imaging Inc. Receives a NIH Grant for Clinical Evaluation and Development of a Diagnostic Multi-modal Intravascular Imaging System
      ...dal probe and necessary hardware in Phase I, followed by extensive clinical trials in phase II before seeking FDA approval and marketing in Phase III

      OCT Medical Imaging Inc. Receives a 2016 NIH Grant for $1,252,899 f...

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    3. Optic Nerve Head Measurements With Optical Coherence Tomography: A Phantom-Based Study Reveals Differences Among Clinical Devices

      Optic Nerve Head Measurements With Optical Coherence Tomography: A Phantom-Based Study Reveals Differences Among Clinical Devices
      Purpose : Optical coherence tomography (OCT) can monitor for glaucoma by measuring dimensions of the optic nerve head (ONH) cup and disc. Multiple clinical studies have shown that different OCT devices yield different estimates of retinal dimensions. We developed phantoms mimicking ONH morphology as a new way to compare ONH measurements from different clinical OCT devices. Methods : Three phantoms were fabricated to model the ONH: One normal and two with glaucomatous ...
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    4. Light-Induced Thickening of Photoreceptor Outer Segment Layer Detected by Ultra-High Resolution OCT Imaging

      Light-Induced Thickening of Photoreceptor Outer Segment Layer Detected by Ultra-High Resolution OCT Imaging
      Purpose : We examined if light induces changes in the retinal structure that can be observed using optical coherence tomography (OCT). Methods : Normal C57BL/6J mice (age 36 months) adapted to either room light (15 minutes to 5 hours, 50500 lux) or darkness (overnight) were imaged using a Bioptigen UHR-OCT system. Confocal histologic images were obtained from mice killed under light- or dark-adapted conditions. Results : The OCT image of eyes adapted ...
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    5. NinePoint Medical Announces FDA 510(k) Clearance of a Real-Time Targeting Feature for the NvisionVLE® Imaging System and the First Clinical Cases in the U.S.

      NinePoint Medical Announces FDA 510(k) Clearance of a Real-Time Targeting Feature for the NvisionVLE® Imaging System and the First Clinical Cases in the U.S.
      ...rm for gastrointestinal applications, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Real-time Targeting™ feature for its flagship product, the NvisionVLE ® Im...
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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