# FDA grants De Novo authorisation to Theranica's Nerivio Migra, a smartphone-controlled migraine wearable

Canonical page: https://technooptimist.io/stories/fda-grants-de-novo-authorisation-to-theranica-s-nerivio-migra-a-4fcbc970
Date: 28 May 2019
About: [Theranica](https://technooptimist.io/companies/theranica.md) · [Nerivio](https://technooptimist.io/neurotech/nerivio.md)
Original source: https://www.medtechdive.com/news/neuromodulation-patch-for-migraine-gains-de-novo-nod/555620/

The FDA authorised Nerivio Migra, a prescription arm patch that delivers electrical pulses to sensory nerves for acute migraine, used at home at the onset of headache or aura. The pivotal trial met its primary endpoint of pain relief at two hours.

## Key facts

- 252-patient pivotal trial: 66.7% pain relief at two hours vs 38.8% placebo
- Significant on three of four secondary endpoints, including pain-free at two hours
- Theranica also closed a $35M Series B led by aMoon

---

The Techno Optimist tracks every frontier of technology, program by program: https://technooptimist.io/ (a Markdown version of any page: add .md to its URL; site map for agents: https://technooptimist.io/llms.txt).
Data API (JSON, realtime stream): https://technooptimist.io/developers. People read 5 pages free, then Reader $10/month; these Markdown pages are open to agents.