The first-ever smartphone-controlled wearable for the acute treatment of migraines has been approved for public use by the U.S. Food and Drug Administration (FDA).

The device, named Nerivio Migra, is used for the acute treatment of migraine, with or without aura, in adults who don’t have chronic migraine. Nerivio Migra is a noninvasive neuromodulation device for the relief of acute migraine pain.

This "first-in-category product" is worn on the upper arm and uses smartphone-controlled electronic pulses to relieve migraine through conditioned pain modulation. This is an endogenous analgesic mechanism in which conditioning stimulation inhibits pain in remote body regions.

Nerivio Migra has been found to be as effective as leading devices and drugs in treating acute migraine, but with fewer and milder side effects.

The FDA approved Nerivio Migra based on the results of a randomized, double-blind, placebo-controlled study involving 252 patients that had two to eight migraines per month.

Participants who used the wearable reported more pain relief than those who used a placebo (66.7 percent against 38.8 percent). They also reported more freedom from pain (37.4 percent vs. 18.4 percent) and relief of the most bothersome symptoms (46.3 percent vs. 22.2 percent) only two hours after treatment.

The study said pain relief lasted some 48 hours after treatment. The rate of device-related harmful events was low and was similar between treatment groups (4.8 percent vs. 2.4 percent).

Theranica, the maker of Nerivio Migra, said device‐related side effects included a sensation of warmth, temporary arm/hand numbness, redness, itching, tingling, muscle spasm and pain in the arm, shoulders, or neck. All were mild and resolved within 24 hours. They did not require medical treatment.

"[The device] can provide patients with significant relief of pain and other migraine symptoms without the side effects presented by drugs," said neuroscientist Messoud Ashina, M.D., Ph.D., of the Danish Headache Center. Dr. Ashina is also president-elect of the International Headache Society,.

Theranica plans to launch Nerivio Migra in the United States this year "at an affordable price."

"We have identified at least 7 different painful conditions that may be relieved by this noninvasive, drug-free technology after appropriate clinical development,” said Alon Ironi, CEO and co-founder of Theranica.

Migraine is reportedly the third most common disease in the world. It has an estimated global prevalence of 14.7 percent of the world’s population.

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