Devices

GE HealthCare Update on Neonatal Incubators

An FDA update says GE HealthCare has conducted preliminary testing on its newly manufactured neonatal incubators that suggests the potential for higher levels of formaldehyde that rapidly decrease over one week. The update is part of the agency’s ongoing evaluation of published literature that found elevated levels of formaldehyde, cyclohexanone, and other volatile chemicals from neonatal incubators. A recent agency letter to healthcare providers says the potential sources of the airborne chemicals include materials used to make the incubators as well as natural and human-made sources external to them.

Based on the information from GE HealthCare, the company recommends that users receiving a new Giraffe OmniBed Carestation or Giraffe Incubator Carestation should run it for a week in a well-ventilated space with maximum heat and humidity prior to placing in clinical use. If the incubator is already in clinical use, then users should continue to use the devices.

GE HealthCare has not received any injury or adverse effects related to potential exposure to formaldehyde in incubators, according to FDA’s update. Currently, there is no evidence that the levels of formaldehyde observed in GE HealthCare incubators have caused any adverse health effects, it says.

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