NuEyne, a Korean electronic medicine R&D company, announced on the 18th that ‘ELEXIR 2.0’, an upgraded version of its migraine treatment device ‘ELEXIR’, has received pre-market approval (510K) from the U.S. Food and Drug Administration (FDA).

The ‘ELEXIR’ device is an electropharmacological medical device that applies electrical pulse stimulation to the trigeminal nerve around the forehead. This treatment helps relieve migraines and reduces their frequency by producing a neuromodulatory effect. It features two treatment modes: an acute mode (60 minutes) for use during a migraine attack and a preventive mode (20 minutes) for daily use. As a wearable personal medical device, ‘ELEXIR’ enables at-home treatment.

Compared to earlier versions, ‘ELEXIR 2.0’ has a new mode selection process, additional packages and components, and offers a more user-friendly experience. Users can now easily keep a migraine diary and complete periodic migraine symptom questionnaires through an app. The app’s AI-based coaching feature provides customized options for patients, and analysis results can be exported as PDF files for seamless communication with medical institutions or insurance companies.

NuEyne stated, “With this FDA pre-market approval, ‘ELEXIR’ has already been recognized for its technology and innovation. It is currently sold in six countries, including Thailand, Poland, India, Taiwan, Brazil, and China. We are focusing on expanding into the United States and Europe, pioneering emerging markets, raising awareness of NuEyne products, and strengthening our position in the global market.”

In addition, NuEyne received 510(k) (pre-market approval) from the FDA for its ADHD electronic medicine ‘ADDNOX’, marketed under the name ‘SMILE’.