Devices

FDA Updates Philips MDRs; 82 Deaths in 2 Months

FDA has updated an ongoing safety communication on Philips Respironics ventilators, BiPAP machines, and CPAP machines to provide updated information about medical device reports (MDRs) that the agency received from 11/1/2022 to 12/31/2022. The devices have been associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in them.

The notice says that during the latest reporting period, Philips submitted over 8,000 MDRs that included 82 deaths. It says the agency’s in-depth review and analysis of the new MDRs will include examining the possible reasons for the increased number of reports. A wide range of injuries have been reported with the MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea, dizziness, nodules, and chest pain, it adds.

Last year, Philips said it is undergoing discussions with the Department of Justice (DoJ) on behalf of FDA about the proposed terms of a consent decree involving the company’s troubled Respironics unit and its ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. In April, the company said it received a DoJ subpoena asking for information on the events that led to recent recalls of the devices (see earlier story).

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