Imalux Niris gets FDA nod

Optical coherence tomography firm Imalux said its Niris Imaging System recently received market clearance from the U.S. Food and Drug Administration.

The firm announced in March 2004 that it had received initial clearance from the FDA to market the Imalux OCT Imaging System. Since then, it has received two additional FDA clearances. The first is for an accessory sheath for the OCT probe, designed to provide a microbial barrier and aid in positioning the probe.

The second and most recent clearance paves the way for the commercialization of the Niris Imaging System. Niris is the result of several design improvements and enhancements to the initial Imalux OCT Imaging System, including interchangeability of different probe lengths and an improved software interface, the Cleveland-based company said.

Imalux plans to begin broad-based marketing and sales efforts for the system in the first quarter of 2005.

By staff writers
January 5, 2005

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