Devices

Philips Respironics Recalls Ventilators

Philips Respironics is recalling (Class 1 device correction) its V30, A30, and A40 ventilators to update their use instructions due to the risk of failure involving the “Ventilator Inoperative” alarm, which can cause therapy interruption or loss. A recall notice says the devices may reboot intermittently, which could stop therapy, and then restart with factory default or current patient settings. It says the devices may also enter an inoperative state (therapy stopped, audible and visual alarms present) after three reboots within 24 hours. “These issues can result in therapy interruption or loss, potentially leading to hypoventilation, hypoxemia, hypercarbia, respiratory failure, or death in vulnerable patients,” it says. To date, there have been eight associated deaths and 13 injury reports.

The ventilators are intended to provide non-invasive support for adults and children with obstructive sleep apnea and respiratory insufficiency. They are for use in institutions or hospitals and are not for life support, but can be used during intra-facility transport, according to the notice.

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