Devices

Roche Cobas Malaria Test Approved

FDA has approved Roche’s cobas malaria test for use on the cobas 6800/8800 Systems to aid healthcare professionals in reducing potential risks of patient infection from transfused blood products. The test provides a “highly sensitive and specific solution to help ensure that infected blood units are removed from the blood supply,” the company says, adding that it screens whole blood samples for the five main species of Plasmodium parasites that are known to cause human infection. The test is intended for use in screening blood, organ and tissue donors.

The qualitative in vitro nucleic acid screening test allows for direct detection of Plasmodium RNA and DNA in whole blood samples from individual human donors, the company says. It can be performed with other routine blood donor screening tests on the cobas 6800/8800 Systems in the U.S. “The test is not intended for use to diagnose Plasmodium infection, for use on cord blood samples or for use on cadaveric blood specimens,” it adds.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome