Cefaly

Cefaly: neuromodulation for the treatment and prevention of migraine

Cefaly is a non-invasive neuromodulation medical device that treats acute migraine attacks and helps prevent future ones. The company presents it as the bestselling over-the-counter device with clinically proven efficacy for this indication. It does not require a prescription and is eligible for health savings accounts (HSA/FSA).

How it works and usage

The device is placed on the forehead after preparing the skin and applying an electrode. The magnetic connection self-aligns instantly. Treatment is applied in 60-minute sessions for migraine relief and 20 minutes daily for prevention. The system emits precise pulses that calm the trigeminal nerve, with adjustable intensity ranging from a gentle vibration to an intense tingling, to adapt to the user's comfort.

Clinical evidence

The company disseminates results from its own studies (ACME, TEAM, and PREMICE): 79% of patients experienced a significant reduction in headache pain after one hour of acute treatment; 56% reported that two hours of acute treatment resolved their most bothersome symptom (nausea or vomiting, sensitivity to light or sound); and 38.1% of patients achieved a greater than 50% decrease in migraine days after three months of preventive treatment. The International Headache Society guidelines on non-invasive neuromodulation state that Cefaly is superior to active placebo in the treatment of acute migraine attacks in adults with episodic migraine, with or without aura.

History and development

CEFALY Technology was founded in Belgium in 2004 with the goal of offering a safe, drug-free option for migraine relief and prevention. In 2008, the first Cefaly device was introduced, worn on a headband. In 2014, it became the first FDA-cleared device for migraine prevention, and that same year the company opened its U.S. office in Darien, Connecticut. In 2017, it received FDA clearance for acute migraine treatment, and in 2020, over-the-counter sales were authorized. In 2024, the company celebrated 20 years of innovation in migraine treatment. In 2025, Cefaly Connected became the most prescribed neuromodulation device by Veterans Health Administration professionals. In 2026, the company introduced a new brand identity and the CEFALY Migraine Relief app.

Corporate profile and patient focus

The company describes itself as a growing technology company headquartered in Belgium and the United States, and notes that it is not part of big pharma. Some of its team lives with migraine, and the company supports research and advocacy for the rights of people with migraine. Its offering includes personalized support through one-on-one coaching, a companion app, and lifetime customer support. The company states that all its claims are backed by real results from more than 300,000 users.

Product and access

The catalog shown on the site includes the CEFALY Connected device, priced at $509.00, with HSA/FSA eligibility and a 90-day risk-free trial. The company also offers electrodes, a quick start guide, scheduling of coaching sessions, and access to a network of certified providers. The CEFALY Migraine Relief app, the CEFALY Connected device, and coaching services are not yet available in the European Union.

Location and contact

Phone: +1 844.475.7100