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Cefaly is a Belgian medical technology company that sells an FDA-cleared, drug-free wearable device designed to treat acute migraine attacks and help prevent future ones. The device is available without a prescription and is eligible for HSA and FSA reimbursement in the United States.

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At a glance

About Cefaly

Founded
2004, Belgium
Headquarters
Belgium and Darien, Connecticut, USA
FDA Clearance
Cleared for acute treatment (2017) and prevention (2014)
Available without prescription
Yes, OTC approved since 2020
HSA/FSA eligible
Yes
Trial period
90-day risk-free trial
Customer support
Lifetime support, one-on-one coaching available
Target audience
Adults with episodic or chronic migraine
Cefaly targets people who live with migraine and are looking for a non-pharmaceutical alternative or complement to medication, including those who experience frequent or chronic episodes. The company was founded in Belgium in 2004 and has built its positioning around clinical evidence, with results from studies such as ACME, TEAM, and PREMICE backing its efficacy claims. The device sits in the premium segment of over-the-counter migraine tools, supported by one-on-one coaching, a companion app, and lifetime customer support. In 2025, Cefaly became the most frequently used neuromodulation device for migraine among veterans served by the Veterans Health Administration.
June 2026

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90-day risk-free trial on the Cefaly device, allowing customers to return the product for a full refund if not satisfied.
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Discount for customers paying with HSA or FSA funds, making the device more accessible for eligible users in the United States.
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Recent

Cefaly in the news

Recent updates and background about Cefaly, summarised in our own words.

Summaries by Image Review based on publicly available sources and our own editing. External links may contain affiliate links.

Frequently asked questions

What others ask about Cefaly

Answers to the most common questions, based on search behaviour and our own research.

Is Cefaly a reliable company to buy from?

Cefaly Technology has been operating since 2004 and holds FDA clearance for both acute and preventive migraine treatment. The device is backed by published clinical studies and is the most frequently prescribed neuromodulation device for migraine within the Veterans Health Administration as of 2025.

Can I return the Cefaly device if it does not work for me?

Cefaly offers a 90-day risk-free trial, which means customers can return the device within that period. The company has a dedicated Returns and Warranty policy listed on its website.

Do I need a prescription to buy the Cefaly device?

No, Cefaly does not require a prescription. It was approved for over-the-counter use in 2020 and can be purchased directly through the website.

Can I use my HSA or FSA to pay for Cefaly?

Yes, the Cefaly device is HSA and FSA eligible, which means eligible customers in the United States can use their health savings or flexible spending account funds to cover the purchase.

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