1. FDA

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    1. Mentioned In 478 Articles

    2. Perimeter Medical Imaging AI Announces Important Milestone in Atlas Ai Project With FDA Investigational Device Exemption (IDE) Approval to Launch Clinical Trial Using Perimeter B-Series OCT With ImgAssist AI in Breast Conservation Surgery

      Perimeter Medical Imaging AI Announces Important Milestone in Atlas Ai Project With FDA Investigational Device Exemption (IDE) Approval to Launch Clinical Trial Using Perimeter B-Series OCT With ImgAssist AI in Breast Conservation Surgery
      ... approval of its Investigational Device Exemption (IDE) application by the U.S. Food and Drug Administration (FDA) to conduct a multi-center, randomized, double-arm study to evaluate the FDA breakthrough-device-designate...
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    3. Notal Vision announces publication of first prospective longitudinal pilot study of daily self-imaging with patient-operated Home OCT in wet AMD patients

      Notal Vision announces publication of first prospective longitudinal pilot study of daily self-imaging with patient-operated Home OCT in wet AMD patients
      ...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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      Mentions: FDA Notal Vision
    4. Overcoming Diagnostic Dilemma and Optimizing Intervention with Optical Coherence Tomographic Guidance in an Angiographically Ambiguous Renal Artery Stenosis Due to Fibromuscular Dysplasia

      Overcoming Diagnostic Dilemma and Optimizing Intervention with Optical Coherence Tomographic Guidance in an Angiographically Ambiguous Renal Artery Stenosis Due to Fibromuscular Dysplasia
      ...in system (ILUMIEN TM Optis System using Dragonfly Optis Catheter TM St. Jude Medical, MA, USA). This is a US FDA approved modality for use in peripheral arteries. OCT imaging of the left renal artery revealed a characte...
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    5. 1-15 of 478 1 2 3 4 ... 30 31 32 »
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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.
      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.
      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.
      In Optovue Q1 2010 Revenue Up 57% Over Same Quarter 2009