Biosense Webster (Diamond Bar, California) reported the launch of the Cartomerge Image Integration Module for diagnosing heart arrhythmias. The Cartomerge enables electrophysiologists to create 3-D electro-anatomical maps that are registered with computed tomography (CT) or MRI images. Merging the CT/MRI image with the Carto XP System 3-D map gives electrophysiologists a more precise view of the heart. The Cartomerge Software Module, used with the Biosense Webster Carto XP Electroanatomical Navigation System, allows physicians to accurately locate and map arrhythmias. The Cartomerge module offers electrophysiologists image registration in three steps: importing the CT or MRI image, processing the image on a radiology or Carto XP System workstation, and registering the images. Additional benefits include full DICOM 3 compatibility, minimal point acquisition, new tools for procedure planning and targeting, and improved speed of the system.
Draxis Health (Mississauga, Ontario) said preliminary results from its Canadian trial indicate that Fibrimage imaged deep vein thrombosis (DVT) but that the review of patient data and charts is required to complete analysis of the trial. The target for filing a new drug submission (NDS) in Canada has been moved to the second half of 2005, pending the outcome of the analysis. The primary endpoint in the trial was the accuracy of Fibrimage for detecting a DVT vs. the defined "truth standard." The preliminary results from the Canadian trial indicate that Fibrimage successfully imaged DVT in patients with clinical symptoms that raised concern as to the presence or absence of DVT. Additionally, a Phase III clinical trial of Fibrimage in Canada closed in late 2004, and the first readings of scans were completed during the first quarter of 2005. Fibrimage was administered as a single intravenous injection and images of suspected sites of DVT in each patient's legs were taken using a gamma camera. The scans for each patient in the trial were benchmarked against the clinical assessment algorithm and the results of ultrasound evaluation. Draxis provides specialty pharmaceutical products in three categories: sterile products, non-sterile products and radiopharmaceuticals.
Nanogen (San Diego) said it has been issued two patents by the U.S. Patent and Trademark Office for technologies related to genetic analysis. Patent No. 6,884,584 claims the use of Nanogen's MGB probes on traditional solid-phase support. Patent No. 6,887,362, relates to devices and methods for performing active, multi-step molecular and biological sample preparation and diagnostic analyses employing immunochemical techniques.
Roche Diagnostics (Indianapolis), a division of F. Hoffman-La Roche, said it has received FDA 510(k) clearance for the Accu-Chek Aviva meter, its newest blood glucose meter for the management of diabetes. The meter will be available for consumers in the U.S. later this year. The Accu-Chek Aviva meter is part of a broad portfolio of diabetes management tools developed by Roche Diagnostics to meet the diverse needs of people with diabetes.