Devices

Breakthrough Status for Meniscus Knee Implant

FDA has granted OrthoPreserve a breakthrough device designation for its Defender meniscus replacement knee implant. The agency has also accepted the device for enrollment in CDRH’s Total Product Life Cycle Advisory Program (TAP). The breakthrough designation covers the implant’s use for treating patients who continue to experience knee pain or impairment following meniscus surgery, which impacts about 250,000 Americans annually, according to the company.

“The anatomical design of the implant restores the normal stabilization and cushioning functions of the meniscus to relieve symptoms and preserve knee joint health,” OrthoPreserve says. The implant is intended to address a treatment gap that exists due to the poor outcomes of the standard of care for meniscus tears, a partial meniscectomy, which removes the damaged tissue, it says.

Because of the designation and TAP enrollment, OrthoPreserve says it will have early and frequent communication with FDA and a priority review for future regulatory submissions.

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