Devices

FDA Clears Gore Hernia Repair Device

FDA has cleared a W. L. Gore 510(k) for its Gore Synecor Preperitoneal Biomaterial hernia repair device, which offers treatment options for the full range of hernia cases, with configurations for both intraperitoneal and preperitoneal placement. The company says the device’s placement between tissue layers “makes tissue ingrowth especially desirable.” It is intended for single-stage preperitoneal, onlay, and retromuscular placements through open, laparoscopic, and robotic applications. Gore says the device is made of three layers: a macroporous knit of dense, monofilament polytetrafluoroethylene fibers that provide strength for a durable single-stage repair and minimizes harboring of bacteria, while two surrounding layers of Gore Bio-A Web, a bioabsorbable copolymer scaffold, help tissue ingrowth and vascularization on both sides of the device.

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