Esophageal Cooling Device controls body temp from within
The FDA has given clearance for Advanced Cooling Technology’s new medical device.
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 de novo approval means the ECD is the first device the FDA has green lit to perform this function, though the technology has already been used clinically in Europe, Canada, and Australia for about a year now.
The ECD is used to cool patient body temperature via the oesophagus. 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.