Top Device Companies

Cepheid Says FDA Approves Its Molecular Diagnostic Tests

Cepheid said it has FDA approval to market a molecular diagnostic test for the presence of bacteria associated with infections resistant to antibiotics. The test is Cepheid’s Xpert C.difficile test capable of detecting a suspect bacterium within 45 minutes. The bacterium causes Clostridium difficile infection that in turn can cause diarrhea, colitis and other intestinal problems. (Click here for more)

“Cepheid Gets FDA Approved For Bacterium Test” – CNBC (AP) (7/13/09)

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St. Jude, Medtronic Devices On List Of Comparative-Testing Proposal

St. Jude Medical and Medtronic and the medical devices they make are at the center of a government proposal urging comparative studies of medical devices as well as drugs. The two companies’ devices that rely on heart-arrhythmia drugs head the list prepared by the federal Institute of Medicine as ripe for comparison studies. Also high on the IOM list are relatively expensive diagnostic products made by Becton, Dickinson and Cepheid for testing antibiotic-resistant staph germs, which the study notes face opposition by some physicians who say they can do the same work using low-tech, anti-infection practices. (Click here for more)

“Marshalling Evidence For What Makes Sense In Health Care” – Barrons (7/6/09)

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Cepheid Develops Rapid Diagnostic To Find Drug-Resistant TB

Cepheid, maker of diagnostic tests, says it now has a rapid and sensitive test for tuberculosis and will offer it at cost in developing countries. Cepheid said the new diagnostic can provide results within two hours and has a system to alert physicians when a patient is infected with a strain resistant to standard treatment. Cepheid’s chief medical officer said TB strains are increasingly becoming resistant to available drugs, making advanced tests more necessary and simple to use. (Click here for more)

“Cepheid Unveils Fast, Low Cost TB Test” – San Francisco Chronicle (3/25/09)

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