Devices

Breakthrough Device Status for Liver/Pancreas Patch

FDA has granted Polyganics a breakthrough device designation for its Liver and Pancreas Sealant Patch, which is designed to prevent fluid leakage after hepato-pancreato-biliary procedures. Currently, there are no approved or cleared alternatives to prevent such leakages, according to the company. The device is made from Polyganics’ proprietary bioresorbable and biologically safe polymers, which are designed to seal-off surgically treated tissue during the healing period. The polymer formulation has been “optimized specifically for HPB surgery, withstanding the interference of aggressive bile and pancreatic fluids,” it says. “It aims to prevent post-operative leakage of fluids from the site of surgery into the abdominal cavity after HPB surgery, and as an adjunctive hemostatic device to control minimal to moderate bleeding.”

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