Multi-Beam OCT Scanner Provides Detailed Images of Subsurface Skin Microstructure at Resolutions Better than Ultrasound and MRI

Multi-beam OCT uses four laser beams to achieve twice the lateral image resolution of traditional single-beam OCT, which is crucial to providing precise, clear images of the subject matter's microstructure. Michelson Diagnostics, Ltd. (Orpington, UK) has announced the award of a CE-marking for its new VivoSight OCT scanner, confirming its compliance with the European Medical Device Directive. The CE-Marking approval enables clinical use of the product in Europe and nonclinical use of the product worldwide. Moreover, the company has been awarded IS0-13485 status, which enables Michelson to manufacture and sell medical products in Europe.

Martin Johns, operations director and quality representative for Michelson Diagnostics said, "These certifications mark an important milestone in the progress of the company. They confirm that our products have met rigorous quality and safety standards required by European regulatory authorities. We are currently preparing our FDA [U.S. Food and Drug Administration] 510(k) submission, which, if successful, will enable clinical sales in the US to commence in the first half of 2010."

When the scanner's hand-held probe is positioned over the tissue, it can capture either two-dimensional (2D) or 3D images of a 5-mm square region. Tissue microstructure features such as epidermis, dermis, and sublayers can be imaged, in addition to subsurface blood vessels. VivoSight captures and displays images in real time, for instant visual feedback. The captured video data can be instantly replayed for review, or stored for later analysis.

Michelson is applying multi-beam OCT to the diagnosis, monitoring, and treatment of cancer, particularly dermal and oral cancer. MDL is working closely with leading clinicians, who believe that multi-beam OCT, by providing a new, detailed window into the body, will accelerate the care of cancer, enabling faster, more accurate treatment that will save lives and produce substantial cost savings to the medical services.

Michelson Diagnostics' medical applications director, Dr. Gordon McKenzie, explained, "Since the VivoSight scanner provides great imaging depth at very good resolution, it could play an important role in the preoperative diagnostics of early carcinomas in the skin. In addition, it can help eliminate the need for multiple biopsies since the technology can provide a view of subsurface tissue that would previously have required extraction."

In vivo trials of the VivoSight scanner have recently begun. The first trial, which is a collaboration between Michelson Diagnostics, Ludwig Maximilians University of Munich (Germany), and University College Hospital (London, UK), will evaluate the capability of the probe to be used to differentiate premalignant and early malignant lesions, and also to demarcate nonmelanoma skin cancers before planned surgical excision. At least 100 patients will be scanned.

Nonclinical applications of the technology will help pharmaceutical cosmetic companies and developers of cosmetic aesthetic equipment to assess the effectiveness of their cosmetic products and aesthetic procedures. Anticipated applications include observing before and after subdermal images of the skin in response to treatments for wrinkles, skin-texture, discoloration, pigmentation, and hair removal.

Michelson Diagnostics is focused in the design and delivery of multi-beam OCT products for scientific research and healthcare imaging.

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