Devices

Integra Recalls Products Over Endotoxin Testing

Integra LifeSciences says it is recalling all products manufactured at its Boston, MA facility due to inadequate endotoxin testing. An internal investigation found deviations with endotoxin testing that may have resulted in the release of products with higher levels of endotoxins than permitted by the product specifications, the company says in an SEC filing. “Higher levels of endotoxins can induce an immune response, leading to a post-operative fever. Although there is no specific indication of any reported product complaints related to high endotoxin levels, the company, in accordance with its commitment to patient safety and product quality, has decided to initiate the voluntary recall and extend the temporary halt of manufacturing at its Boston facility to implement additional detection and quality controls.”

Products affected by the recall include SurgiMend, PriMatrix, Revize and TissueMend products. Integra says it will resume manufacturing after it implements improved detection and quality controls. Depending on how long the manufacturing stoppage lasts, the company says it could take upwards of a $60 million earnings hit this year. “Products manufactured at the Boston facility represent approximately 5% of the company’s consolidated revenues,” 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