Bio Product Guide » Lab Equipment

FDA clears Applied Biosystems’s diagnostic testing

Jim Marino — Tue, 07 Oct 2008 07:48:00 +0000

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.

ThromboVision commences clinical trials for T-Guide(R)

Jim Marino — Fri, 07 Mar 2008 15:50:01 +0000

ThromboVision Inc., a biomedical diagnostics company, has commenced clinical trials of its ThromboGuide (T-Guide) Platelet Function Monitor. Four main research institutes have initiated enrollment and data collection. ThromboVision’s President and CEO, Edward R. Teitel, said that the 510(k) application to the FDA is expected in early 2008.

The T-Guide(R) consists of a disposable test kit and a point-of-care base unit. The system will help physicians improve their cardiac patients’ lives by individualizing antiplatelet therapy that they use to prevent heart attacks, strokes and stent occlusions.