OCT scanner from Michelson Diagnostics receives FDA 510(k) clearance
The US Food & Drug Administration (FDA) has awarded its 510(k) clearance for Michelson Diagnostics’ (London, UK) VivoSight OCT scanning product. For clinical use, FDA 510(k) 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 to the human body.”
According to the company, 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 a handheld probe.
Company CEO, Jon Holmes, said 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.
Holmes can be contacted via [email protected] or the Michelson Diagnostics website www.michelsondiagnostics.com.