FDA expands approval for STMS system in migraine.- eNeura

eNeura announced that it has obtained a new 510(k) clearance from the FDA for the STMS system, expanding the product indication of acute and preventive treatment of migraine to include children 12 years of age and older. The company received clearance for acute and preventive treatment of migraine in adults in 2017.

With this FDA clearance, the sTMS is now the only migraine product in the United States indicated both for the acute and prophylactic treatment of migraine headache in adults and children (12 years of age and older). More than four million children, 12 years and age and older suffer from migraine headache in the US and more than 36 million people in the US suffer from migraine headache.