Devices

FDA Update on Heater-Cooler Devices

FDA has provided an update on its ongoing monitoring of heater-cooler devices and the risk of nontuberculous mycobacteria infections in patients who have undergone cardiothoracic surgery using the devices. The agency says that last month it cleared the Spectrum Medical Quantum Heater-Cooler and the compatible Qura Quantum PureFlow Heat Exchangers. “Instead of using water, the Quantum Heater-Cooler device regulates the temperature of a glycol-based heat transfer fluid (HTF), which then enters the compatible PureFlow heat exchangers to ultimately regulate the temperature of a patient’s circulating blood,” the update says. “The Quantum Heater-Cooler's HTF demonstrated it mitigates the risk of contamination of the device by suppressing the growth of nontuberculous mycobacteria and other bacteria.”

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