Research & Development
The FDA authorises marketing of new ClearMate device to help treat carbon monoxide poisoning
15 March 2019 -

Public health company The US Food and Drug Administration Thursday approved the marketing of its new ClearMate device for the quick removal of carbon monoxide from the body under its De Novo premarket review pathway.

The US FDA granted the marketing authorisation of ClearMate to Thornhill Research Inc.

Carbon monoxide can kill within minutes through unintended exposure from poorly-maintained heating systems, or gas stoves or gas-powered generators used for heat or power during storms. The most common symptoms of carbon monoxide poisoning are headache, dizziness, weakness, upset stomach, vomiting, chest pain and confusion.

The agency stated ClearMate consist of a gas mixer, valves, meters, breathing circuits, an oxygen reservoir, a mask and hoses and works by speeding up the elimination of carbon monoxide from the body. It delivers both 100% oxygen to the patient, as well as a mixture of oxygen and carbon dioxide, causing the patient to breathe faster. The increased breathing allows a normal amount of oxygen to attach to hemoglobin and be carried where it is needed throughout the body.

In conjunction, the US FDA reviewed data from the company's multiple clinical studies, which tested the effectiveness of the device on 100 patients. The studies demonstrated the device was effective at eliminating carbon monoxide. The combination of oxygen and carbon dioxide in the ClearMate resulted in a faster elimination of carbon monoxide than treatment with 100% oxygen alone but was not faster than hyperbaric oxygen therapy.



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