Drugs

Luminex Assay for Group B Strep Cleared by FDA

FDA has cleared a Luminex 510(k) for the Aries Group B Streptococcus (GBS) Assay for antepartum detection of GBS colonization in pregnant women. This is the third assay the agency has cleared for use on the Aries System.

The company says that GBS infection is a leading cause of neonatal morbidity and mortality, causing meningitis, pneumonia and septicemia in newborns and their mothers. One in four pregnant women are colonized with GBS, with most not exhibiting symptoms; however, it can be transmitted to the newborn during delivery. If not treated, GBS can result in illness or even death in the first week of a newborn's life.

The real-time polymerase chain reaction-based qualitative in vitro diagnostic test can detect GBS nucleic acid from 18-24 hour Lim broth enriched vaginal-rectal swab specimens obtained from pregnant women, Luminex says. “It offers higher sensitivity and increased accuracy when compared to culture, and a reduced turnaround time of two hours after enrichment, compared to 48 hours for culture,” 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

Read more

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