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.”
For more information, visit: www.michelsondiagnostics.com