Michelson Diagnostics has received the European CE Mark for its VivoSight optical coherence tomography (OCT) scanner, enabling its clinical use in Europe for the diagnosis, monitoring, and treatment of oral and other cancers.
In addition, Michelson has been awarded IS0-13485 status, which enables the company to manufacture and sell medical products in Europe.
The VivoSight scanner uses multibeam OCT to provide images of surface tissue at extraordinarily high resolution -- better than 7.5 microns lateral and 10 microns axial resolution -- revealing previously hidden details of tissue microstructure, according to Michelson. Multibeam 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 microstructure, the company noted.
The company is currently preparing a 510(k) submission for the U.S. FDA, which, if successful, will enable clinical sales in the U.S. to commence in the first half of 2010, according to Martin Johns, operations director and quality representative for Michelson.
Copyright © 2009 DrBicuspid.com
