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FDA approval
Theranica receives FDA approval for migraine treatment device
Preventive Healthcare
Jan 25, 2021
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Preventive Healthcare

Preventive Healthcare

Jan 25, 2021

Theranica receives FDA approval for migraine treatment device

FDA approval

  • Founded in 2016, Theranica is a digital therapeutics company focused on developing affordable devices for chronic pain conditions. Cited as Time’s best inventions of 2019, Nerivio, the company’s flagship device, is accessible to patients in the US through any licensed healthcare provider, including telehealth platforms such as Cove and UpScript. 

  • The smartphone-controlled device is worn on the upper arm for 45 minutes, where the nerves are stimulated to induce conditioned pain modulation using Remote Electrical Neuromodulation to treat migraine symptoms. The device can be used for 12 treatments, after which the company provides a prepaid envelope for the device to be sent for recycling. 

  • Studies published in the medical journal Headache showed that 71% of adolescents that used Nerivio reported pain relief after two hours of use, while 35% claimed complete freedom from pain, with pain relief sustained for 24 hours in 90% of cases. Functional ability improved in 69% of the patients at the two-hour mark with no serious side effects. 

  • Israel-based Theranica, a digital health tech company that develops devices for chronic pain management, has received the US Food & Drug Administration (FDA) approval to market Nerivio, a wearable device used for the drug-free treatment of episodic or chronic migraines, for patients above 12 years of age. The device was previously approved for adults in October 2020.

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