FDA Policy/General

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Molecular diagnostics company Biodesix has acquired Seattle-based Integrated Diagnostics on undisclosed terms. The transaction includes Integrated’s lead oncology product, XL2 test, which is intended to rule out cancer for patients with suspicious lung nodules.

Becton, Dickinson and Co. has completed its acquisition of TVA Medical, which develops vascular access solutions for patients with chronic kidney disease requiring hemodialysis. The addition of TVA Medical enables BD to offer the everlinQ endoAVF System, a new endovascular arteriovenous (AV) fistula creation technology.

Bovie Medical has agreed to sell to Symmetry Surgical its core electrosurgical and cauteries business for $97 million in cash. Bovie is the developer of J-Plasma, a patented plasma-based surgical product for cutting, coagulation and ablation of soft tissue.

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