WAT Medical this week won FDA clearance for over-the-counter use of its HeadaTerm 2 wearable anti-migraine device.
HeadaTerm 2 uses neuromodulation technology. It releases targeted electrical impulses that increase the pain tolerance of the wearer. It is FDA-cleared for the preventative treatment of migraine headaches and is available without a prescription in the U.S.
HeadaTerm2 doesn’t use an app and allows all controls to be managed with one button for ease of operation. The approach simplifies the user experience and eliminates the need for complex installations or additional software.
The company said the device has been clinically proven safe and effective at reducing migraine symptoms. According to a study published in the American Journal of Emergency Medicine, HeadaTerm 2 can be up to 27% more effective than oral medications at relieving migraine symptoms. Other clinic studies of the device will begin this year.
WAT Medical said it plans to support headache patients, specifically veterans, through strategic partnerships and donations through the VHA Headache Centers of Excellence Program. The device will be available without a prescription online this month.
