eNeura Inc., a privately held medical technology company, has announced the filing of a 510(k) with the U.S. FDA for the SpringTMS® transcranial magnetic stimulation (TMS) device, a progression from its already approved CerenaTMS solution for migraine treatment.
Migraine headaches are characterized by intense pulsing or throbbing pain in one area of the head accompanied by nausea and/or vomiting and sensitivity to light and sound. Migraine is three times more common in women than in men and affects more than 10 percent of people worldwide. About one third of migraine sufferers experience an aura: a visual, sensory or motor disturbance immediately preceding the onset of a migraine attack.
SpringTMS operates along the same principles as eNeura’s CerenaTMS, the first medical device to be cleared by the FDA to treat migraine. The user applies TMS to the back of the head using both hands and presses a button to generate a focused, single pulse of magnetic energy that treats the migraine headache non-invasively and without discomfort.
SpringTMS is a second-generation medical device based on eNeura’s ground-breaking CerenaTMS™, which received FDA clearance in December 2013 for the treatment of pain caused by migraine headaches preceded by an aura. eNeura says SpringTMS is more patient-friendly and portable compared to the previous generation device. It is already CE Marked in Europe and available by prescription in the UK.
David K. Rosen, President and CEO of eNeura, commented, “As a company, our focus is to provide patients with innovative and effective TMS medical technologies. By filing a 510(k) with the FDA for SpringTMS we have completed the next step on the path to bringing our most advanced TMS device to patients in the US. SpringTMS provides more user-friendly features compared to CerenaTMS, including a more compact size and shape, better portability and greater ease of use for the patient. We are optimistic that the SpringTMS will launch in 2014, having the advantage of improving upon our FDA-cleared predicate device.”
Source: eNeura, Inc., PR Newswire