Drugs

FDA Clears Xtant Medical for Cervical Screw Indication

FDA has cleared an Xtant Medical Holdings 510(k) for a posterior cervical screw indication on the Certex Spinal Fixation System, which the company says can be linked to the Fortex Pedicle Screw System and the Xpress Minimally Invasive Pedicle Screw System with rod-to-rod connectors and transition rods. “This extended use of Certex screws in the cervical spine enhances stability for posterior cervical procedures allowing an opportunity to increase fixation options to promote fusion,” Xtant Medical says. The Certex Spinal Fixation System is also intended to assist in restoring spinal column integrity for a limited time in the absence of fusion in patients with advanced stage tumors involving the cervical spine in whom life expectancy is medically determined to be insufficient to permit achievement of fusion.

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