• AgaMatrix (Salem, New Hampshire), a manufacturer of blood glucose monitoring products, reported that it has received FDA clearance to sell its discrete blood glucose monitoring system (BGMS), the Wave 1. The Wave 1 system is being distributed in the U.S. by Liberty Medical, as its Liberty brand BGMS, and by other distributors internationally. The Liberty BGMS is the only system that uses WaveSense, a suite of dynamic electrochemistry and digital signal processing technologies that enables superior analytical performance for biosensors. The system features a unit of measurement safety lock designed to prevent misinterpretation of results, a double redundant power supply for more reliable data memory, six user-settable alarms, and hypoglycemic and hyperglycemic alerts.

• Arrow International (Reading, Pennsylvania), a manufacturer of disposable catheters and related products, said the SmartSeal Hemostatic peelable dialysis sheath is available in the U.S. both individually and in select chronic hemodialysis catheter kits. The sheath's dual hemostatic valve is designed to minimize risk of air embolism, minimize blood loss and reduce clinicians' exposure to blood-borne pathogens during the catheterization procedure. SmartSeal is also engineered to ease insertion, with features including easy-to-grip tabs; an easy-to-peel sheath with break-away hemostatic valve; and a sheath tip designed to enable smooth, atraumatic transition during insertion.

• Gen-Probe (San Diego) reported that it has submitted to the FDA an amendment to its biologics license application for the Procleix Ultrioassay on the Procleix enhanced semi-automated system (eSAS). The Ultrioassay was developed to simultaneously detect HIV-1, hepatitis C virus and hepatitis B virus in donated blood, plasma, organs and tissues. The amendment responds to questions asked by the FDA in an October 2005 complete review letter regarding the Ultrioassay. Separately, Gen-Probe reiterated that it intends to submit a 510(k) application for the fully automated Procleix Tigris system to run the Procleix WNV assay, a blood screening test for the West Nile virus, by the end of April. The WNV assay was approved by the FDA in December 2005 to run on the eSAS. The company intends to submit a 510(k) application for the Ultrioassay on the Tigris system following clearance of the system for the WNV assay.