Devices

Moximed Knee Shock Absorber Cleared

FDA has cleared a Moximed 510(k) for its MISHA Knee System, an implantable shock absorber for use in patients with medial knee osteoarthritis (OA). The device is indicated for those who failed to find relief from non-surgical or surgical treatment, and are ineligible for, or unwilling to undergo, joint replacement due to age or absence of advanced OA. The implant is placed on the medial knee and moves with the natural joint, reducing about 30% of the peak force on the knee with every walking step, according to Moximed.

“Moximed utilized the clinically established benefits of load reduction on diseased joints to design the MISHA Knee System,” the company says. Implanted during an outpatient-compatible procedure, the device demonstrated “superiority over high tibial osteotomy (HTO), a well-established surgery with decades of demonstrated clinical results, in its recent pivotal clinical study.” It says

OA is a common, debilitating condition, affecting over 32 million adults in the U.S., Moximed says. It develops when the joint’s natural shock absorbers, cartilage and meniscus, no longer cushion the joint from daily activities, leading to chronic pain and activity limitation.

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