The FDA has expanded the age indication for Theranica's Nerivio remote electrical neuromodulation device for migraine treatment in patients aged eight and above. Previously, the device was only approved for patients 12 years and older. This makes it the first FDA-cleared non-drug therapy for acute treatment and the only prescribed preventive treatment of migraine for children in this age group.

The expanded approval was supported by real-world study data of children aged 6–11 years. The study showed that 72.2% of patients reported consistent headache relief and 83.3% reported consistent functional disability relief two hours post-treatment. No adverse events were reported in the study.

Analyst QuickTake: Nerivio received FDA approval for treating acute migraines in May 2019, and, in January 2021 , the firm obtained FDA clearance to market its product as a treatment for episodic or chronic migraines while expanding treatment to adolescents. Its closest competitor, gammaCore from electroCore , is the only other device approved for adolescents.