1. FDA

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    1. Mentioned In 296 Articles

    2. 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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    3. Study shows VivoSight OCT is able to differentiate between actinic keratosis (AK) and basal cell carcinoma (BCC) by quantification of signal intensity and layer thickness

      Study shows VivoSight OCT is able to differentiate between actinic keratosis (AK) and basal cell carcinoma (BCC) by quantification of signal intensity and layer thickness
      ...tial focus in dermatology. The ‘Dynamic OCT’ technology is a software add-on and has CE regulatory clearance; FDA 510(k) clearance is currently pending. The Company’s vision is for the VivoSight OCT system to become the...
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    4. Avinger Announces FDA Clearance and U.S. Launch of Breakthrough Treatment for Patients with Peripheral Artery Disease

      Avinger Announces FDA Clearance and U.S. Launch of Breakthrough Treatment for Patients with Peripheral Artery Disease
      ...announced that the company has received 510(k) clearance from the United States Food and Drug Administration (FDA) for an enhanced version of its Pantheris™ lumivascular atherectomy system, the first-ever image-guided at...
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    5. Optical Coherence Tomography as a Tool for Real-Time Visual Feedback and Biomechanical Assessment of Dermal Filler Injections: Preliminary Results in a Pig Skin Model

      Optical Coherence Tomography as a Tool for Real-Time Visual Feedback and Biomechanical Assessment of Dermal Filler Injections: Preliminary Results in a Pig Skin Model
      ...ost FDA approved fillers last 3 to 24 months, depending on composition and injection site. There are numerous FDA-approved dermal fillers of varying compositions, with the most common being hyaluronic acid. Various fille...
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    6. 1-15 of 296 1 2 3 4 ... 18 19 20 »
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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