FDA Grants De Novo Authorization to BrainCool’s Cooral System

The FDA has granted De Novo marketing authorization to BrainCool’s Cooral system to cool the inside of the mouth and help prevent oral mucositis in chemotherapy patients.

The attachable oral device, which delivers closed-loop circulatory cooling, is easy to use and maintenance-free, the Sweden-based company said.

Oral mucositis has been reported as the single most debilitating complication of cancer therapy, often causing severe pain and ulceration, which can cause delays in treatment. The cooling system is an alternative to ice water, which can be painful and poorly tolerated over an extended treatment time.

The Cooral system received Breakthrough Device designation in 2021.

The De Novo pathway is for novel medical devices for which there is no legally marketed predicate device and for which general controls alone, or general and special controls, provide a reasonable assurance of safety and effectiveness for the intended use.