Devices

Spineology Gains De Novo for OptiMesh

FDA has granted Spineology Inc. a de novo marketing authorization for its OptiMesh Expandable Interbody Fusion System. The grant follows completion of the company’s SCOUT (Spineology Clinical Outcomes Trial) study. “OptiMesh is a unique mesh device that expands in three dimensions, enabling surgeons to perform interbody fusion procedures through the smallest access in the spine industry,” the company says.

The SCOUT trial, according to Spineology, showed “substantial improvements in low back pain and a reduction in functional limitations at six, 12, and 24 months. It also demonstrated a 98% fusion rate at 24 months, as seen on CT scans assessed by two independent radiologists, and about a 90% ‘excellent’ or ‘good’ patient satisfaction scores at six, 12, and 24 months post-procedure,” the company 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