Devices

FDA Clears DePuy 510(k) for Maxframe Fixation Device

FDA has cleared a DePuy Synthes 510(k) for its recently launched Maxframe Multi-Axial Correction System, an external circular fixation device used to gradually correct bone or soft tissue deformities in the arm, leg, foot or ankle. The device is indicated for the following treatments in adults and in both children (ages 3-12) and adolescents (ages 12-21) in which the growth plates have fused or will not be crossed with hardware: fracture fixation (open and closed), pseudoarthrosis of long bones, limb lengthening (epiphyseal or metaphyseal distraction), joint arthrodesis, infected fractures or nonunions, correction of bony or soft tissue deformities, and correction of segmental defects.

The device’s 3D planning software helps improve accuracy of the deformity correction plan, “which may reduce overall treatment time while potentially improving procedural efficiency and reducing costs,” the company says. “Patients undergoing treatment with the Maxframe System are responsible for adjusting the struts on the device as per their custom treatment plan.”

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