eNeura Receives FDA 510(k) Clearance for sTMS mini to Treat and Prevent Migraine in Adults and Adolescents

VCBeat (WeChat ID: vcbeat) has learned that medical technology company eNeura recently announced that its product, sTMS mini, has received FDA 510(k) clearance. This technology offers a new option for the treatment and prevention of acute migraine.

Migraine is a common chronic neurovascular disorder that often begins in childhood and adolescence, with the peak incidence occurring in young and middle-aged adults. It is reported that in the United States, more than 4 million children aged 12 years and older suffer from migraines, while the number of adult patients exceeds 36 million.

eNeura is a medical technology company headquartered in California, USA, dedicated to developing devices for the treatment and prevention of migraines. Its flagship product, sTMS mini, upon receiving FDA approval, will become the only medical device indicated for both adolescent (aged 12 and above) and adult patient populations.

TMS (Transcranial Magnetic Stimulation) is a painless, non-invasive therapeutic technique that has gained widespread recognition in the fields of clinical psychiatry, neurological disorders, and rehabilitation. Based on the frequency of stimulation pulses, TMS can be categorized into three modes: single-pulse TMS (sTMS), paired-pulse TMS (pTMS), and repetitive TMS (rTMS).

The sTMS mini utilizes sTMS technology, which primarily employs magnetic stimulation to induce mild electrical currents that modulate hyperactive neurons in the brain for therapeutic purposes. Patients simply place the device on the back of the head and press a button to deliver focused magnetic pulses for the treatment and prevention of migraine attacks.

As the first portable, easy-to-use, non-invasive TMS (Transcranial Magnetic Stimulation) device, the sTMS mini allows for on-demand treatment at home, in the office, or while traveling. However, it is currently available only by physician prescription.

“sTMS mini represents a major breakthrough in the field of migraine treatment in the United States,” said Dr. David K. Rosen, President and CEO of eNeura. “Typically, migraine patients must rely on medications to alleviate pain, each of which may carry debilitating side effects. For many years, it has been deeply concerning that children, as a special population, have had almost no safe and effective options for the treatment and prevention of migraines. Now, our sTMS mini has demonstrated efficacy comparable to migraine medications in clinical studies, but without the risk of disability or other side effects.”

It is reported that, in addition to the United States, sTMS mini has also been approved in Europe, Australia, and Singapore.

(Compiled by: Feng Yutong)