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VivoSight Gains 510(k) Clearance

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ORPINGTON, UK, Jan. 15, 2010 -- The London-based developer and manufacturer of optical coherence tomography (OCT) products, Michelson Diagnostics Ltd., has been awarded 510(k) clearance from the US Food & Drug Administration (FDA) for its VivoSight OCT scanning product. The VivoSight device is the first Fourier-Domain OCT scanner to receive FDA 510(k) clearance outside the field of ophthalmology, according to the company. It provides subsurface images of tissue at higher resolutions than is possible with existing technologies, including ultrasound, CT and MRI, using an easy-to-use lightweight handheld probe. “This is...Read full article

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    Published: January 2010
    Glossary
    ophthalmology
    Ophthalmology is a branch of medicine that focuses on the anatomy, physiology, and diseases of the eyes and visual system. Ophthalmologists are medical doctors who specialize in the diagnosis, treatment, and prevention of eye disorders and diseases. They are trained to provide comprehensive eye care, including medical, surgical, and optical interventions. Key areas within ophthalmology include: General eye care: Ophthalmologists perform routine eye examinations to assess visual acuity,...
    optical coherence tomography
    Optical coherence tomography (OCT) is a non-invasive imaging technique used in medical and scientific fields to capture high-resolution, cross-sectional images of biological tissues. It provides detailed, real-time, and three-dimensional visualization of tissue structures at the micrometer scale. OCT is particularly valuable in ophthalmology, cardiology, dermatology, and various other medical specialties. Here are the key features and components of optical coherence tomography: Principle of...
    scanner
    1. A device used to trace out an object and build up an image. One of the most common of these types is video scanning. The scanning takes place inside the television tube as electrons, guided by electron optics, sweep linearly across a tube face coated on the inside with a phosphorescent material. A scanner can convert a paper drawing or photograph into pixels on a display screen. Scanners are also used to relay information in optical data processing. 2. A device that automatically measures or...
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    510(k) clearanceAesthetic LasersBiophotonicsBusinessCT scansDermal ImagesdermatologyFDAFDA approvalHandheld ProbeImagingJon Holmesmedical imagingmelanomaMichelson DiagnosticsMRImultibeam OCTOCTophthalmologyoptical coherence tomographyoral cancerPharmaceutical Cosmetic Companiesscannerskin cancerSurface ImagestissuesultrasoundUS Food & Drug AdministrationVivoSight


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