Michelson Diagnostics of London, UK has received FDA clearance to market the VivoSight optical coherence tomography (OCT) scanner in the US. The device, which uses a class I laser to shine light through tissue, is intended for use by dermatologists for analyzing skin tissue and lesions within the skin up to a depth of 2 millimeters.
From a Michelson press release:
VivoSight 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 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.
From the VivoSight brochure:
The VivoSight scanner uses Multi-Beam Optical Coherence Tomography (OCT), a revolutionary laser-based imaging modality that provides images of surface tissue at extraordinarily high resolution – better than 7.5 μm lateral and 10 μm vertical resolution – far higher than is possible with other modalities, revealing previously hidden details of tissue microstructure.
VivoSight with ‘topical’ hand-held probe is designed to enable capture of images of surface tissue microstructure to a depth of up to 2 mm. The probe is positioned over the tissue and can capture either 2D or 3D images of a 5 mm square region. Tissue microstructure features such as epidermis, dermis and sub-layers can be imaged, as can subsurface blood vessels.
Light, ergonomically designed, wipe-clean probe, with adjustable ‘stand-off’ to enable the user to maintain a correct focus distance. The probe utilizes the Michelson Diagnostics’ patented Multi-Beam OCT optics for high resolution images, a visible red spot to aim the scan, and an X-Y (3D) scanning capability.
Press release: VivoSight OCT scanner Receives FDA 510(k) Clearance…
Product page: VivoSight OCT Scanner…
Flashback: Multi-Beam OTC Probe From Michelson Announced