Devices

Class 1 Recall on Respironics Ventilators with Faulty Alarms

FDA has classified as Class 1 a Philips Respironics recall of all V60 and V60 Plus ventilators because an internal power fluctuation may cause the ventilator to shut down unintentionally either with or without any visible or audible alarms. “The power fluctuation causes a reboot of the backup alarm controller, which may lead to a complete shutdown of the ventilator without warning,” a recall notice says. “Affected ventilators may cease ventilation either with or without alarms. Such failures may lead to patients being deprived of oxygen for an extended time, which could cause serious adverse health consequences and death.” Since 4/14, FDA says there have been reports of four injuries and one death associated with the use of the recalled devices.

The ventilators are intended to support patient breathing in those with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea. The ventilators are intended to be used in hospitals or other institutional settings.

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