Devices

FDA Issues Safety Notice on Nitric Oxide Delivery System

FDA has issued a correction notice for NOxBOX Ltd.’s NOxBOXi Nitric Oxide Delivery System after reports of dosing fluctuations when the device is used with the Bunnell LifePulse High Frequency Jet Ventilator and possibly other conventional ventilators. The agency warned that the problem can interrupt nitric oxide therapy and lead to serious, potentially life-threatening complications.

NOxBOX Ltd., a subsidiary of Linde Gas & Equipment Inc., says customers had reported swings greater than 20% from the intended nitric oxide dose under specific LifePulse settings. Such fluctuations may reduce oxygen levels in the blood (desaturation) or increase pressure in the pulmonary artery, which carries blood from the heart to the lungs, it says. According to the company, three serious injuries have been reported.

The company says its NOxBOXi system is used to deliver and monitor inhaled nitric oxide therapy, along with nitrogen dioxide and oxygen levels, in a patient’s ventilator circuit. Nitric oxide is commonly used in critical care settings to support oxygenation in neonates and other vulnerable patients. It says it is developing a new software version that will correct the dosing fluctuation problem.

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