FDA approves eNeura's brain-stimulation device to treat migraines

eNeura's Cerena TMS--Courtesy of eNeura

California's eNeura won FDA approval for its portable migraine-fighting device, heading to the U.S. market with a transcranial magnetic stimulation tech that can relieve pain in some of the most extreme cases.

The device, called Cerena TMS, is designed to treat migraines that are preceded by a sensory disturbance, using a magnetic pulse to stimulate the brain's occipital cortex and alleviate pain. In a pivotal trial on 201 patients, nearly 38% of migraine sufferers who used Cerena TMS were pain-free two hours after onset compared to about 17% in the control group, and nearly 34% of those in the treatment arm stayed that way after 24 hours, besting the 10% rate of the control segment, the FDA said.

Roughly 10% of people suffer from migraines, according to the agency, and one-third experience sensory disruptions beforehand. Cerena TMS is already CE marked and commercially available overseas, and now, with the FDA's blessing, eNeura can hit the ground running with a U.S. launch.

ENeura is the first to win FDA approval for a migraine-treating TMS application, but the company is hardly alone in finding a therapeutic angle in what was once only an imaging technology. Israel's Brainsway won FDA approval in January for Deep TMS, using a similar mechanism to treat depression. Neuronetics has a CE-marked device that works the same way, and Cervel Neurotech raised $14.1 million this year to develop a TMS system for chronic pain.

- read the release

Suggested Articles

The FDA has approved its first contact lens designed to effectively slow the progression of nearsightedness in children, starting in ages 8 to 12.

Novartis tapped Biofourmis to develop tracking programs for heart failure patients, as the latter acquired Biovotion, makers of clinical wearables.

Janssen is planning its first completely virtual clinical trial, using personal smartphones and wearable devices with no in-person site visits.