FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Advanced Cooling Therapy Snags FDA De Novo Clearance for Esophageal Cooling Device

June 25, 2015
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Advanced Cooling Therapy’s first product, the Esophageal Cooling Device, has secured FDA de novo clearance. The Chicago, Ill.-based devicemaker says the product is the only temperature modulation device on the market that uses the esophageal space to cool or warm patients.

The device can be used in operating rooms, recovering rooms, emergency rooms or the ICU.

The product won CE Mark certification last year, and is available in Canada and Australia. Advanced Cooling Therapy plans an imminent U.S. launch.

The FDA grants de novo clearance for novel or breakthrough Class I or II medical devices with low to moderate risk. — Jason Scott