The Esophageal Cooling Device gets FDA's rare de novo clearance for innovative devices

Advanced Cooling Therapy's Esophageal Cooling Device has just received the FDA's de novo clearance. That's a strong sign that it's an innovative technology, for the de novo clearance is reserved for low- to moderate-risk devices that don't have a "substantially equivalent" predecessor on the market. The device controls patients' whole-body temperature using temperature modulation equipment that's inserted into the esophagus. More

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