www.fdanews.com/articles/207620-nociras-eponymous-acute-migraine-treatment-designated-an-fda-breakthrough-device
Nocira’s Eponymous Acute Migraine Treatment Designated an FDA Breakthrough Device
May 2, 2022
The FDA has designated Tempe, Ariz.-based Nocira’s acute migraine treatment a Breakthrough Device for use by individuals aged 18 and older.
The drug-free device uses controlled puffs of air in the ears to treat migraine attacks.
The breakthrough designation was supported by positive results from a 59-patient placebo-controlled study.
Twenty minutes after treatment with either Nocira's device or a sham version, 60 percent of those treated with the genuine device had no pain vs. 7 percent of those treated with the placebo, the company said.