Devices

FDA Alert on Synovo Hip Implants

FDA is alerting healthcare providers to not purchase or implant Synovo’s Total Hip System because modifications to the original device design were not cleared by the agency. “Three components of the system, the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing, have been significantly modified from the devices that were cleared by the FDA,” a safety notice says. “The safety and effectiveness of the Synovo Total Hip System, including the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing, have not been established.”

For patients who have received a Synovo hip implant after 2019, FDA says they should contact their healthcare provider if they experience any symptoms, such as new or worsening pain, loosening, grinding or other noise, inability to bear weight, or weakness of the hip or knee on the side of the implant.

FDA says that it became aware in 2022 that significant modifications had been made to the device. “ Following an inspection, the FDA issued a Warning Letter to Synovo,” the alert says. “The Warning Letter listed several violations and instructed the company to immediately stop manufacturing the modified devices and take prompt action to correct the violations addressed in the letter.”

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