• Baxter Healthcare (Deerfield, Illinois) reported that it has received approval from FDA for its new Aviva line of intravenous solutions and will begin a “limited launch“ of the line in 2H06. Aviva containers are made of non-PVC (non-polyvinyl chloride) film, contain no latex and offer a DEHP-free [di (2-ethylhexyl) phthalate-free] fluid pathway to patients. The Aviva container line, which features Baxter's EnlightenedHRBC bar code, includes common and widely used intravenous (IV) solutions, complemented by non-DEHP IV administration sets. Products packaged in Aviva containers will initially be available to a limited number of pilot center sites for specialty use, the company said. Baxter will be conducting a targeted launch with a select group of customers in 2006 and anticipates broader availability of the product line in 2007.

• etrials Worldwide (Morrisville, South Carolina), an eClinical software and services company, reported the availability of its etrials Clinical Trial Management System (CTMS). etrials said the CTMS system improves the effectiveness of clinical studies by providing pharmaceutical, biotech and contract research organizations with logistical tools to manage clinical studies. CTMS provides users with access to data via standard and customizable reports to best manage sites and project team staff. The system also provides automated alerts, monitoring report templates, grant payment management and flexibility in granting user access to data which can be limited to a single project or site. The included maintenance module allows users to configure the software for specific clients, projects and sites. The new CTMS system was developed based on a technology acquired from Quintiles Transnational in April 2005.

• Gen-Probe (San Diego) said it has submitted to the FDA a 510(k) application for use of the fully automated, high-throughput Procleix Tigris system to screen donated human blood, tissue and organs for West Nile virus (WNV) with the Procleix WNV assay. The Procleix WNV assay was approved by the FDA in early December for use on the enhanced semi-automated Procleix system (eSAS). WNV is a mosquito-borne virus associated with a human form of the disease ranging from mild, flu-like symptoms to severe neurological disease. The Tigris system is approved in many countries outside the U.S. to screen donated human blood, tissue and organs with the Procleix Ultrio assay.