Devices

Robot Authorized to Disinfect Medical Surfaces

FDA has granted Xenex Disinfection Services a de novo marketing authorization for the company’s LightStrike+ device, a high-intensity, broad-spectrum ultraviolet (UV) light robot intended for use in reducing pathogens on non-porous, high-touch surfaces in healthcare environments. The robot uses a xenon lamp to create high-intensity pulsed UV light that reduces the number of pathogens on surfaces to prevent transmission from one patient or healthcare worker to the next, according to the company. The authorization was supported by “rigorous testing performed on over 10,000 samples of vegetative bacteria and Clostridiodes difficile (C.diff) spores,” it says.

The robot is intended to perform “microbial reduction on non-critical medical device surfaces free from visual soiling in the healthcare environment following manual cleaning and disinfection practices,” Xenex says. They are authorized for use in healthcare facilities, including unoccupied operating rooms, hospital rooms, and other clinical settings where non-critical medical devices may be present.

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