Devices

BD Files 510(k) for Required Alaris Pump Update

Becton, Dickinson has submitted a 510(k) for the BD Alaris System that updates the infusion pump to address FDA regulatory issues (see earlier story) raised last year. The device, which the company says is used on about 70% of patients undergoing infusion therapy, has been hampered by a recent cybersecurity threat and a recall of its bezel assembly because of a defect that could result in free flow, over-infusion, under-infusion, or interruption of infusion. The company earlier said it was caught off-guard and had not believed the device modifications were going to require a 510(k) submission.

BD says the 510(k) submission is intended to bring the regulatory clearance for the BD Alaris System up to date, implement updated features and address open recall issues, including a new software version that will provide clinical, operational and cybersecurity updates. “The 510(k) submission is the first step in the review process with the FDA, and we look forward to working through the FDA review process to obtain clearance for the updated BD Alaris System,” it says.

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