Imalux Corporation receives final FDA clearance to market the Niris imaging system

Cleveland 04 January 2005Imalux Corporation, a medical device company and developer of the Niris Imaging System based on Optical Coherence Tomography (OCT) technology, has recently received market clearance from the United States Food & Drug Administration (FDA) for the Niris System. Imalux will begin intensive, broad-based marketing and sales efforts for the system in the first quarter of 2005.


Imalux announced in March 2004 that it had received initial clearance from the FDA to market the Imalux OCT Imaging System. Since then, the company has received two additional FDA clearances, one for an accessory sheath for the Imaging System probe, designed to provide a microbial barrier and aid in positioning the probe. The second, and most recent, cleared the Niris Imaging System for commercialization. Niris is the result of several significant design improvements and customer-focused enhancements to the initial Imalux OCT Imaging System, including interchangeability of different probe lengths and an improved software interface.

Optical Coherence Tomography uses harmless, low power near infrared light to create high quality, real-time medical images. It is particularly useful for the visualization of structural disruptions in soft tissue. Imalux intends to deploy the technology as a diagnostic tool and as an adjunct to guided surgery to satisfy a number of unmet medical needs.

Imalux is a Cleveland-based corporation that is commercializing Optical Coherence Tomography technology originally developed at the Institute of Applied Physics of the Russian Academy of Sciences, one of the main progenitors of OCT technology worldwide. OCT is a proven technology that is on the verge of becoming the sixth major imaging modality.

The company's Niris Imaging System provides real-time, high spatial resolution, two-dimensional, cross-sectional depth visualization of tissue microstructure. The compact, point-of-care system creates images utilizing harmless near infrared light. The spatial resolution of the system is on the order of 0,01 mm, surpassing conventional ultrasound imaging by an order of magnitude. Imalux OCT technology has been under evaluation with physicians in a number of speciality areas and has been evaluated with over 3000 patients worldwide at leading medical institutions including the Cleveland Clinic Foundation and the George Washington University Medical Center.

Leslie Versweyveld

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