Advanced Cooling Therapy, a company based in Chicago, IL, received de novo 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 novo approval means this is the first device the FDA has green lit to do such a trick, though the technology has already been used clinically in Europe, Canada, and Australia for about a year now.
Here’s a promo video for the ECD:
Product page: Esophageal Cooling Device…
Source: Advanced Cooling Therapy…
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