Drugs

Globus Gets HDE for Scoliosis Corrector

FDA has granted Globus Medical a humanitarian device exemption to allow the marketing of the Reflect Scoliosis Correction System, which the company says is designed to correct progressive scoliosis in young patients while preserving motion, maintaining stability, and allowing for future modulated growth. “Unlike rigid metal rods for fusion, Reflect uses a flexible, durable cord to harness the power of innate patient growth for correction,” it says. “The flexible cord is tensioned on the convex side to control the curve, while allowing growth on the concave side.” The implants are inserted through incisions between the ribs.

The device is indicated for skeletally immature patients who require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis. Such patients should have a major Cobb angle of 30 to 65 degrees, and their osseous structure should be dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging, Globus says. Patients should have also failed bracing or are intolerant to brace wear.

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