The U.S. Food and Drug Administration has granted 510(k) clearance to Applied Biosystems Inc.’s new 7500 Fast Dx Real-Time PCR Instrument for use in conjunction with the new CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel from the U.S. Centers for Disease Control and Prevention. The novel CDC diagnostic assay, along with the 7500 Fast RT- PCR Instrument, is designed to set standards of precision and specificity of diagnostic results for influenza virus testing in the United States. This new test has the power to detect viruses accurately and quickly.

The U.S. Food and Drug Adminstation has cleared expanded labeling to Baxter Healthcare Corporation for the first antimicrobial needle-less intravenous (IV) connector, V-Link Luer-activated device (LAD) with VitalShield protective coating. With a new federal policy that restricts the reimbursement for healthcare-associated infections (HAIs) medical professionals are looking for useful technologies that can help lower the contamination risk posed by a broad array of pathogens within the hospitals. V-Link with VitalShield kills 99.99 % of the six most common pathogens known for causing infections related to catheter.

The U.S. Food and Drug Administration has given clearance to Teleflex Medical for launching its Hudson RCI Neb-U-Mask® in the market. The product is a respiratory device used for the treatment of acute asthma exacerbation. It allows for the simultaneous delivery of aerosolized drug and high concentrations of medical gases like oxygen or heliox. Having a patented innovative wye design, the system features a nebulizer connection and MDI adaptor, a non-rebreathing mask with a 750ml gas reservoir bag, and color coded tubing.

The U.S. Food and Drug Administration has approved an immune globulin product called Gamunex for the treating a rare autoimmune disorder, CIDP. It is characterized by progressive muscle weakness and impaired sensory function in the limbs.
Designated as an orphan drug by the FDA, manufacturers have been provided with financial incentives to develop Gamunex. Caused by the damage to the myelin sheath that protects the nerve fibers, CIDP can be treated by Gamunex which is made from the plasma in human blood containing antibodies that fight infections. Talecris Biotherapeutics Inc. is the manufacturer of Gamunex.