Devices

Bioporto Pediatric Kidney Injury Assay Cleared

FDA has cleared a Bioporto 510(k) for its ProNephro AKI (NGAL) biomarker assay for detecting pediatric acute kidney injury. The immunoassay is intended for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine. “Determination of NGAL is intended to be used in conjunction with clinical evaluation in pediatric patients (greater than or equal to three month) without underlying kidney disease admitted to the intensive care unit (ICU) for the management of cardiovascular or respiratory compromise or who have had a solid organ or bone marrow transplant,” the company says.

ProNephro AKI is intended to be used in the first 24 hours of ICU admission, according to Bioporto. “In patients with low SCr [serum creatinine] levels, indicative of no acute kidney injury (AKI) or AKI Stage 1, the test can be used as an aid to identify patients at risk to develop moderate to severe AKI (Stage 2/3) 48 to 72 hours after the assessment,” it says.

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