Devices

FDA Clears 2 Thermo Scientific Tests

FDA has cleared Thermo Scientific 510(k)s for its EliA RNA Pol III and EliA Rib-P tests for aiding in the diagnosis of systemic sclerosis (SSc; scleroderma) and systemic lupus erythematosus (SLE). “RNA Polymerase III is a criteria marker for SSc with both diagnostic and prognostic value,” the company says. “Additionally, in patients who are positive for RNA polymerase III, up to 70% may have no other SSc associated antibodies present.”

The company says some SLE patients present with monospecific ribosomal P antibodies, and detecting these using indirect immunofluorescence has been shown to be an unreliable method. “The EliA Rib-P test is designed with optimal sensitivity and specificity and can be used to support the diagnosis of SLE, particularly in ANA [antinuclear antibodies] negative patients,” 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