Devices

FDA Approves MR-Conditional Esteem Labeling

FDA has approved magnetic resonance-conditional labeling for Envoy’s Esteem hearing implant, the only middle ear implant to receive approval for such labeling in both 1.5 and 3.0 Tesla scanning environments. The company says surgeons and audiologists who have worked closely with hearing implants have seen as a limitation of middle ear implants that they all were contraindicated for high-resolution 3.0 Tesla scans, and all but one were also contraindicated for 1.5 Tesla scans.

The company says that the lack of magnets in the Esteem reduces safety and comfort risks associated with magnetic coupling during an MRI, and also helps minimize the amount of image distortion around the implant.

Envoy describes the Esteem as a fully-implanted active middle ear implant designed to alleviate moderate to severe sensorineural hearing loss in adults. The company says Esteem is a hearing loss solution for those who do not get enough from their hearing aids or who do not wear their hearing aid because of 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