Devices

GE Healthcare Recalls Newborn Incubators

GE Healthcare has recalled (Class 1 instructions for use update) its Giraffe Omnibed Carestation and Incubator Carestation due to preliminary testing of newly manufactured devices that suggested higher levels of formaldehyde exposure for neonates in the first week of device use. The levels rapidly decrease after the first week of use, a recall notice says.

GE HealthCare implemented a process beginning 9/5 to reduce the formaldehyde levels from new neonatal incubators before distribution, the notice says, adding that the use of devices made before 9/5 may cause serious adverse health consequences, including neurological impairment or respiratory problems (such as asthma, decreased lung function, inflammation, or irritation) and nasal, mouth or throat cancer. The notice also offers instructions on how to reduce the levels for the earlier devices before clinical use.

Giraffe Omnibed Carestation and Incubator Carestation are neonatal incubators that are intended to help create an optimal environment for newborns that need support in regulating their body temperature.

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