Advanced imaging company Imalux has received European regulatory approval for the next-generation of its product.
The company has begun worldwide shipments of its new Niris 1300e imaging system. Cleveland-based Imalux originally received the CE Mark for an earlier version of the Niris system several years ago, chief financial officer Tom Barnish said.
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The Niris Imaging System uses near-infrared light to produce high-resolution images of tissues in the body through a process called optical coherence tomography (OCT). The resolution of the Niris cross-sectional images is about 100 times higher than those produced by ultrasound, which uses sound instead of light waves to create images.
The system is used primarily for early stage cancer detection in three specialties: obstetric; urology; and ear, nose and throat, Barnish said.
The new version of the Niris boasts increased acquisition speed, enhanced image analysis tools and user interface improvements, according to a statement from Imalux.
Imalux originally received U.S. regulatory clearance for the Niris in 2004. The new version of the system won’t require another clearance from the U.S. Food and Drug Administration, Barnish said.
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The University of North Carolina at Charlotte has received the first installation of the next-generation system in the U.S. Additional systems will be delivered to the University of Magdeburg and University of Munich-Grosshadern in Germany in the next few weeks, according to the statement.
The Niris has been installed at about 40 customer sites across the world, Barnish said.
