The FDA granted a de novo request for approval of a smartphone-controlled electroceutical for the acute treatment of migraine with or without aura in adult patients who do not have chronic migraine. The Nerivio Migra is a wearable device that goes on the upper arm and this device is controlled from your smartphone.
It was invented by Theranica, an Israeli company, with the goal of relieving migraine pain without the side effects of medication.
Nerivio Migra is the 1st FDA approved low cost, low side effect wearable device for the acute treatment of migraine.
The Nerivio Migra has 2 electrodes on the inside of the arm band.
Through a patient’s smartphone, it generates electrical impulses, sending them to the brain to release the body’s own painkillers to the nerves.
Similar to a nicotine patch, you place the Nerivio Migra device on your arm above the elbow. The device communicates wirelessly via Bluetooth with your smartphone, which regulates the electrical pulses and sets a timer. A 45-minute treatment can bring relief for pain within two hours.
In tests, 66.7% of the 252 migraine sufferers in 13 clinics felt relief after 2 hours, compared to 28% of those using a placebo, or dummy device.