Drugs

FDA Clears Vallum Nanotechnology PEEK Spinal Fusion Device

FDA has cleared a Vallum Corp. 510(k) to market a polyetheretherketone (PEEK) spinal interbody fusion device with a PEEKplus nanotextured surface created by the company’s proprietary Accelerated Neutral Atom Beam technology. “Nano-scale concavities of 20-50 nanometers are created by the impact of argon atoms across the entire existing microsurface of the PEEK to create the nanotexture of PEEKplus,” the company says. “Importantly, nanotexturing below 100 nanometers has been shown to be beneficial to osteoblast functions that are necessary to grow bone and promote fusion.” Vallum says its nanotexturing technology can be inexpensively applied to any fully manufactured PEEK interbody device without altering its design or size, and without affecting mechanical or chemical properties.

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