Healthcare Industry News: coherence tomography
News Release - January 12, 2010
Michelson Diagnostics VivoSight(TM) OCT Scanner Receives FDA 510(k) Clearance
ORPINGTON, United Kingdom, Jan. 12, -- (HSMN NewsFeed) -- Michelson Diagnostics Ltd, the London, UK based developer and manufacturer of Optical coherence tomography (OCT) products, announced today that the US Food & Drug Administration (FDA) has awarded it 510(k) clearance for its VivoSight(TM) OCT scanning product.For clinical use, FDA 510(k) K093520 applies: "VivoSight(TM) is a Multi-Beam Optical coherence tomography (OCT) system indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body."
VivoSight(TM) is the first Fourier-Domain OCT scanner to receive FDA 510(k) clearance, outside of the field of ophthalmology. The patented "Multi-beam OCT" technology provides sub-surface images of tissue at far higher resolution than is possible with existing technologies such as ultrasound, CT or MRI, in 2D and 3D and in real time, using an easy-to-use lightweight hand-held probe.
Michelson's CEO, Jon Holmes, said that the 510(k) award was received more quickly than expected. "This is a very exciting development, as it enables US researchers to use our VivoSight in a clinical setting. 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 for efficacy." He added that the company is keen to hear from US dermatologists and companies with potential applications for VivoSight(TM).
The Michelson Diagnostics VivoSight(TM) OCT scanner will be exhibited at SPIE BIOS 2010, San Francisco Moscone Conference Centre, January 23-24th 2010, and will be available for private demonstration immediately after.
About Michelson Diagnostics
Michelson Diagnostics is the leading innovator in the design and delivery of Multi-Beam Optical coherence tomography (OCT) products for scientific research and healthcare imaging. Founded in 2006, it is based in SE London, UK. www.michelsondiagnostics.com
Jon Holmes can be contacted via enquiries@md-ltd.co.uk or the Michelson Diagnostics website.
Source: Michelson Diagnostics
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