News & Media
VivoSight OCT scanner Receives FDA 510(k) Clearance
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 OCT scanning product.
For clinical use in the US 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 - US Federal law restricts this device to sale by or on the order of a physician.
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.
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.
The Michelson Diagnostics VivoSight 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.
