eNeura has announced the filing of a 510(k) application with the US Food and Drug Administration (FDA) for its SpringTMS transcranial magnetic stimulation (TMS) device, a second-generation medical device based on the company's CerenaTMS.
Recently, the CerenaTMS obtained FDA approval for the treatment of pain caused by migraine headaches preceded by an aura: a visual, sensory or motor disturbance immediately preceding the onset of a migraine attack.
SpringTMS operates along the same principles of CerenaTMS. 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.
According to eNeura, SpringTMS is more patient-friendly and portable than the previous generation device.
eNeura president and CEO David Rosen noted as a company, its 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," Rosen added.
SpringTMS has already obtained CE Mark approval in Europe and is available by prescription in the UK.