Devices

CDRH Joins Gates Foundation on Analytic Methods

FDA says CDRH is partnering with the Bill and Melinda Gates Foundation to create new analytical methods to help develop breath-based diagnostic devices for disease detection in underserved populations. In an online post, CDRH director Jeffrey Shuren and Office of Science and Engineering Laboratories director Ed Margerrison say the new methods are intended to identify multiple chemicals or biomarkers in complex chemical mixtures and thus to increase the potential for chemical characterization to identify multiple chemicals when used in premarket device testing.

“Due to high costs and the complexity of the instruments needed to perform an analysis, disease detection in remote and impoverished areas can be extremely challenging,” the statement says. “These new methods are intended to help developers create a more efficient and affordable option that could be more easily deployed across populations living in rural and remote areas.”

Shuren and Margerrison say that with the support of a $1.9 million grant from the foundation, CDRH and the National Institute for Standards and Technology will be able to work on developing a pathway for identification and an opportunity to treat disease in rural and medically underserved areas.

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