FDA Expands Clearance for Theranica’s Wearable Migraine Device
The FDA has granted an expanded marketing clearance for Theranica’s migraine relief device Nerivio, allowing the wearable product to be used for adolescent patients.
The wireless prescription device is now cleared for the acute treatment of episodic or chronic migraine in patients aged 12 and older. It is worn on the patient’s upper arm and is controlled using a smartphone app that provides personalized treatments and a migraine diary to track treatment sessions and headaches.
The noninvasive, remote electrical neuromodulator was first cleared by the FDA in May 2019 for the acute treatment of migraines with or without aura in patients 18 years and older.