The FDA has granted 510(k) clearance to NeuroVice’s PATI (protector against tongue injury) device to maintain an open airway and prevent oral injuries during a seizure.

The single-use device, which stops the teeth from touching the tongue, lips and cheeks, is designed to stay in place during a seizure.

With 12 million seizure-related emergency calls to 911 occurring each year in the U.S., the company said its device can be an intervention for emergency medical technicians’ use.