FDA Roundup: May 6, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA cleared the Spectrum Medical Quantum Heater-Cooler and the compatible Qura Quantum PureFlow Heat Exchangers used to warm or cool a patient during cardiopulmonary bypass procedures. 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 Quantum Heater-Cooler's HTF demonstrated it mitigates the risk of contamination of the device by suppressing the growth of nontu...