Devices

Alert on Hyperbaric Oxygen Devices

FDA is cautioning health care providers and facilities about the safe use of hyperbaric oxygen therapy (HBOT) devices following reports of serious injuries and deaths tied to their use. In a recent safety communication, the agency urges providers to strictly follow manufacturers’ instructions and to reinforce fire prevention measures when operating HBOT chambers, which deliver 100% oxygen at elevated air pressure. Oxygen-rich environments can increase the risk of fire, it says, adding that it also recommends ensuring proper grounding of equipment and maintaining thorough staff training to reduce potential hazards.

FDA says it has received recent reports of fires in HBOT chambers that led to severe injuries and fatalities. The root cause of these incidents has not yet been determined, but regulators emphasize that while such events are rare, they can have devastating consequences.

HBOT is commonly used for conditions such as decompression sickness, carbon monoxide poisoning, and certain wounds. The devices are classified as Class 2 medical devices and are typically cleared through FDA’s 510(k) pathway.

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