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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 a very exciting development, as it enables US researchers to use our VivoSight in a clinical setting,” said Jon Holmes, CEO at Michelson Diagnostics. “There are many potential applications in the dermatology space with strong commercial potential, each of which will need to be studied so that we can establish claims of efficacy.”

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Jan 2010
The branch of medicine involved in the study of the anatomy, functions, diseases and treatments of the eye.
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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