FDA De Novo Clearance for Acute Treatment of Migraines won by Nerivio Migra

FDA De Novo Clearance for Acute Treatment of Migraines won by Nerivio Migra

A smartphone- operated electroceutical device for treating migraine headaches, namely Nerivio Migra has been developed by Israel based company, Theranica. The company recently won FDA De Novo clearance for newly developed device.

The device works to create a “Conditional Pain Modulation” response as it delivers electronic pulses into the skin where it is worn- upper arm. The device mitigates the effect of migraine and is indicated for patients who do not suffer from the condition of chronics migraine. The device in designed with a power button on it. However, to control its operations, it needs to be synced with an accompanying smartphone application.

A prospective, randomized, double-blind, placebo-controlled, multi-center pivotal study involving 252 patients at a dozen different clinics resulted in putting the device in its own category, the De Novo clearance. According to the director of the Hartford Healthcare Headache Center in Connecticut, and lead Principal Investigator of the study, Dr. Brian Grosberg, MD. a “high efficacy ratio for single as well as multiple attacks, both at two and 48 hours after treatment was reflected in the study of Nerivio Migra.

For now it has been revealed that by later this year the device will be made available in the United States. Additionally, other pains could also be treated with this technology according to Theranica. In a published statement, Alon Ironi, CEO and co-founder of Theranica said that the company’s commitment towards clinical development, expanding the use of remote electrical neuromodulation therapy for additional indication is simultaneous with the launch of Nerivio Migra in the United States market later this year at an affordable price.

As many as seven different painful conditions that may be relieved by this non-invasive, drug-free technology after appropriate clinical development have also been identified by the company.

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