Devices

FDA Helping Philips to Resolve MRI-related Shortages

FDA is recommending that health care providers discuss alternative magnetic resonance imaging (MRI)-guided breast biopsy options for patients if facilities are unable to perform these due to a shortage of Philips Invivo MRI breast biopsy grid plates and other Philips Invivo MRI disposables.

Late last month, Philips issued a notice on its Web site informing customers about shipment delays and shortages of certain MRI coil disposables. “The impacted products in our MR coil disposable portfolio have now been released for shipment in the U.S.,” it said. “Shipments are continuing and backorder times are decreasing.”

The agency says it is working with Philips to help resume deliveries and to prioritize shipments to facilities in regions that have no alternative imaging centers where these procedures can be performed. “Imaging facilities notified the FDA of this shortage in 7/2022, and we have been working with Philips to identify potential contributing factors and mitigation strategies,” it adds. The shortage is expected to be resolved by year end.

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