Michelson Diagnostics, the UK based developer and manufacturer of Optical Coherence Tomography (OCT) products, has received the FDA 510(k) clearance for VivoSight OCT scanning product.
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.
For clinical use, FDA 510(k) K093520 applies: ‘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.’
Jon Holmes, CEO of Michelson, said: “The 510(k) award was received more quickly than expected. This is an 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. The company is keen to hear from US dermatologists and companies with potential applications for VivoSight.”