Devices

FDA Clears Hybrid Sacroiliac Joint Implant

FDA has cleared a Spinal Simplicity 510(k) for the Patriot-SI Posterior Implant System as part of a hybrid sacroiliac (SI) joint fusion construct to be used with the Liberty-SI lateral transfixing system. The device is intended for sacroiliac joint fusion for conditions including sacroiliac disruptions and degenerative sacroiliitis, according to the company. “The Patriot SI technology is constructed intentionally as a cannulated implant, designed for repeatable, reproducible techniques, with the implant traveling directly over the guidewire for precision placement in the SI Joint,” it says.

The additively (3D)-manufactured titanium implant is available in one size, fixating both the sacrum and ilium via external threads, the company says. The procedure involves the lateral insertion of a small titanium Liberty-SI implant, transfixing the SI joint to stabilize and fuse the joint, it says, adding that the technique ensures “robust decortication of the bone to prepare the joint for 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