Devices

FDA Discusses 2 New Trilogy Ventilator Issues

FDA says two issues appeared at the end of 2022 in certain reworked Philips Respironics Trilogy 100 and 200 ventilators. An agency statement says those ventilators were recalled in 6/2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. It says the latest issues are:

the silicone sound abatement foam installed to replace the PE-PUR foam may separate from the plastic backing due to adhesive failure; and
residual PE-PUR sound abatement foam was observed by the company in some reworked Trilogy 100 and 200 ventilators that were returned to customers.

Philips has temporarily paused reworking the Trilogy units, FDA reports. The agency says it is aware of complaints received from Philips customers outside the U.S. but is not aware of any injuries or deaths associated with the recall in the U.S.

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