Devices

Panel Backs Seeker Newborn Lysosomal Screener

FDA’s Clinical Chemistry and Toxicology Devices Panel of the Medical Devices Advisory Committee has unanimously voted to recommend that the benefits from the use of Baebies’ Seeker System outweigh the risks in the intended use population. The device comprises a SEEKER Analyzer, a SEEKER 4-Plex Assay Kit, SEEKER Cartridges, the Spot Logic software and quality control materials. It uses digital microfluidic technology to measure multiple lysosomal enzymatic activities quantitatively from newborn dried blood spot specimens for newborn screening. The company is seeking a de novo petition approval for the device’s use for measuring lysosomal enzymes from newborn dried blood spot specimens. Reduced activity of these enzymes may be indicative of a lysosomal storage disorder.

During the voting, some panel members did express concerns about the test’s unknown false positive rate and false negative rate, and its analytical performance. However, they did believe results were reliable for it to be used as a screening test.

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