Advanced Cooling Therapy, a company based in Chicago, IL, received de **vo FDA clearance for its Esophageal Cooling Device (ECD), in effect creating a new category of regulated medical devices.
The ECD is used to cool patient Body temperature via the esophagus. It is a disposable, single use Device that has three channels, two of which are for running fluids and the third one for drainage and decompression.
It’s positioned*pretty much just like an oro-gastric tube would be, connected to temperature Control equipment, and thus running to Control Body temperature from within. The de **vo approval means this is the First Device the FDA has green lit to do such a trick, though the tech**logy has already been used clinically in Europe, Canada, and Australia for about a year **w.