• Dade Behring (Deerfield, Illinois) reported FDA clearance for the use of its Advanced D-Dimer assay as an aid in the diagnosis of venous thromboembolism (deep vein thrombosis or pulmonary embolism). The clearance included performance data with a defined cutoff value for the Dade Behring BCS System and Sysmex CA-1500 System. The assay also is for use on Dade Behring's BCT System, and Sysmex CA-7000 and CA-560 Systems.

• Diopsys (Pine Brook, New Jersey) said clinical results of its new pediatric vision test, the Enfant Pediatric Vision Testing System, show a 97% sensitivity in detecting vision deficits in children as young as six months of age, according to a study published in the December 2004 issue of the Journal of the American Association for Pediatric Ophthalmology and Strabismus. The Enfant, a non-invasive, child- friendly device that tests for visual deficits using visual- evoked potential technology, records the brain's response to light and can detect vision problems early in a child's life when these conditions are correctable.

• Imalux (Cleveland) reported that its Niris Imaging System, based on optical coherence tomography (OCT) technology, received FDA clearance. Imalux said it would begin broad-based marketing and sales efforts for the system in 1Q05. The company received initial clearance from the FDA last March to market the Imalux OCT Imaging System. Since then, it 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 design improvements and customer-focused enhancements to the initial Imalux OCT Imaging System, including interchangeability of different probe lengths and an improved software interface. OCT uses low-power, near-infrared light to create high-quality, real-time medical images.

No Comments