Devices

FDA Approves Asuragen Test for Monitoring Leukemia Treatment

FDA has approved an Asuragen de novo submission to allow marketing of the QuantideX qPCR BCR-ABL IS Kit, the first nucleic acid-based quantitation test for use during treatment of chronic myeloid leukemia (CML) patients. The device uses blood specimens from patients with CML to measure the amount of BCR-ABL fusion genes, which can be used to estimate the amount of leukemia cells in a patient when treated with BCR-ABL targeted therapies. “The clinical performance of the QuantideX qPCR BCR-ABL IS Kit was evaluated by a study using banked samples across three U.S. clinical laboratories from 98 patients,” an agency release says. “Study results demonstrated a significant difference in the outcomes of patients who achieved reduced levels of BCR-ABL from targeted therapy from those who did not.”

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