ORPINGTON, England, Sept. 17, 2009 (GLOBE NEWSWIRE) -- Michelson Diagnostics has announced the award of a CE-mark for its new VivoSight Optical Coherence Tomography (OCT) scanner, confirming its compliance with the European Medical Device Directive. The CE-Mark approval enables clinical use of the product in Europe and non-clinical use of the product worldwide. In addition, 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 Ltd., 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 510(k) submission, which, if successful, will enable clinical sales in the US to commence in the first half of 2010."
About VivoSight
The VivoSight scanner with hand-held probe uses Multi-Beam OCT to provide images of surface tissue at extraordinarily high resolution -- better than 7.5 microns lateral and 10 microns axial resolution -- far higher than is possible with other modalities, revealing previously hidden details of tissue microstructure. Multi-Beam OCT uses four laser beams to achieve double the lateral image resolution of conventional single-beam OCT, which is crucial to providing crisp, clear images of the subject matter's micro-structure.
When the hand-held probe is positioned over the tissue it can capture either 2D or 3D images of a 5mm square region. Tissue microstructure features such as epidermis, dermis and sub-layers can be imaged, as can 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.
Clinical Applications
Michelson is leading the way in 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 pre-operative 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 sub-surface 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 in London, UK, will assess the capability of the probe to be used to differentiate premalignant and early malignant lesions, and also to demarcate non-melanoma skin cancers before planned surgical excision. At least 100 patients will be scanned.
Non Clinical Applications
Non-clinical applications will help pharmaceutical cosmetic companies and developers of cosmetic aesthetic equipment to evaluate the effectiveness of their cosmetic products and aesthetic procedures. Anticipated applications include observing before and after sub-dermal images of the skin in response to treatments for wrinkles, skin-texture, discoloration, pigmentation and hair removal.
About Michelson Diagnostics
Michelson Diagnostics is a leading innovator in the design and delivery of Multi-Beam Optical Coherence Tomography (OCT) products for scientific research and healthcare imaging. Founded in 2006, it is based in SE London, UK.