Devices

Steris Gets EUA for N-95 Respirator Decontamination

FDA has issued a second emergency use authorization (EUA) for decontaminating compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings. The EUA was issued to Steris Corp. for the Steris V-Pro 1 Plus, maX and maX2 Low Temperature Sterilization Systems with the Steris N95 Decontamination Cycle (non-lumen cycle) which uses vaporized hydrogen peroxide. “The vapor fills the sterilization chamber, penetrates the device and sterilizes exposed surfaces,” an FDA release says. The device is capable of processing 10 respirators at once through a process that takes about 28 minutes to complete. Each respirator can be processed up to 10 times for single-user reuse, it says, adding that about 750,000 N95 respirators per day could be decontaminated.

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