1. FDA

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    1. Mentioned In 260 Articles

    2. Image quality metrics for optical coherence angiography

      Image quality metrics for optical coherence angiography
      We characterized image quality in optical coherence angiography (OCA)en faceplanes of mouse cortical capillary network in terms of signal-to-noise ratio (SNR) and Weber contrast (Wc) through a novel mask-based segmentation method. The method was used to compare two adjacent B-scan processing algorithms, (1) average absolute difference (AAD) and (2) standard deviation (SD), while varying the number of lateral cross-sections acquired (also known as the gate length, N). AAD and ...
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    3. New Journal Article Highlights Mechanical Effects of Orbital Atherectomy and Rotational Atherectomy in Treating Heavily Calcified Coronary Lesions

      New Journal Article Highlights Mechanical Effects of Orbital Atherectomy and Rotational Atherectomy in Treating Heavily Calcified Coronary Lesions
      ...dback Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries. To date, nearly 2...
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    4. Closed loop tracked Doppler optical coherence tomography based heart monitor for the Drosophila melanogaster larvae

      Closed loop tracked Doppler optical coherence tomography based heart monitor for the Drosophila melanogaster larvae
      A fruit fly larva (top) was continuously tracked for continuous remote monitoring. A heartbeat trace of freely moving larva (bottom) was obtained by a low coherence interferometry based doppler sensing technique. This paper presents a novel instrument for biosciences, useful for studies of moving embryos. A dual sequential imaging/measurement channel is assembled via a closed-loop tracking architecture. The dual channel system can operate in two regimes: (i) single-point Doppler ...
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    5. “How Does Breast Cancer Develop?” Pilot Grants Awarded to Multidisciplinary Teams Using the Intraductal Approach to Advance Breast Cancer Prevention

      “How Does Breast Cancer Develop?” Pilot Grants Awarded to Multidisciplinary Teams Using the Intraductal Approach to Advance Breast Cancer Prevention
      ...to treat various breast health conditions. Atossa’s medical devices have not been cleared nor approved by the U.S. Food and Drug Administration for the potential uses and treatments identified in the above proposed studi...
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    6. Michelson Diagnostics closes £2.5 million First Tranche of £4.0 million Series B fundraising Smith & Nephew as Cornerstone Investor

      Michelson Diagnostics closes £2.5 million First Tranche of £4.0 million Series B fundraising Smith & Nephew as Cornerstone Investor
      ...of-care, real-time tissue imaging device.  The patented technology, which has CE/TGA regulatory-clearance and FDA 510(k) approval in the United States, provides clinicians with continuous images of the epidermis and supe...
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    7. Bausch + Lomb Introduces New Software and Advanced OCT Imaging System for VICTUS® Femtosecond Laser Platform

      Bausch + Lomb Introduces New Software and Advanced OCT Imaging System for VICTUS® Femtosecond Laser Platform
      ...ly owned subsidiary, Bausch + Lomb, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an advanced Swept Source OCT (Optical Coherence Tomography) imaging system and updated software for i...
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    8. Bioptigen Awarded $458,000 from North Carolina Biotechnology Center to Advance Intrasurgical OCT System Development

      Bioptigen Awarded $458,000 from North Carolina Biotechnology Center to Advance Intrasurgical OCT System Development
      ...investigational device, limited by United States law to investigational use. The device is not cleared by the FDA to be marketed, sold, or distributed within the United States. Bioptigen Inc. is an innovative medical t...
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    9. 1-15 of 260 1 2 3 4 ... 16 17 18 »
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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