eNeura Files 510(k) with the FDA for SpringTMS? Migraine Treatment - Applied Clinical Trials

ADVERTISEMENT

See our 2013 Buyers Guide Digital Edition.
eNeura Files 510(k) with the FDA for SpringTMS? Migraine Treatment 510(k) filing follows recent FDA clearance of CerenaTMS"


eNeura Files 510(k) with the FDA for SpringTMS® Migraine Treatment

510(k) filing follows recent FDA clearance of CerenaTMS™

PR Newswire

SUNNYVALE, Calif. and BALTIMORE, Jan. 27, 2014 /PRNewswire/ -- eNeura Inc., a privately held medical technology company, announced today that it filed a 510(k) with the U.S. Food and Drug Administration (FDA) for the SpringTMS® transcranial magnetic stimulation (TMS) device.  SpringTMS is a second-generation medical device based on eNeura's ground-breaking CerenaTMS™, which recently received FDA clearance 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 is more patient-friendly and portable compared to the previous generation device, and is already CE Marked in Europe and available by prescription in the UK.

CerenaTMS was the first medical device to be cleared by the FDA to treat migraine and SpringTMS operates along the same principles.  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.

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."

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 at the onset of pain.

About eNeura
eNeura Inc., a privately held medical technology company, is pioneering the use of portable, non-invasive Transcranial Magnetic Stimulation (TMS) devices for treatment of migraine.  Prescribed by physicians but designed for patient use, it is the first truly portable, convenient TMS product that will allow migraine patients to administer treatment as needed—at home, in the office or on the go.  The eNeura SpringTMS® Total Migraine System device is currently CE Marked in Europe and is available in the United Kingdom.  The company's first generation CerenaTMS™ device received clearance from the FDA for the treatment of migraine preceded by aura in December 2013.  For more information on eNeura and TMS please visit http://www.eneura.com.   

Media Contacts:

Jason Rando / Claire Sojda

Tiberend Strategic Advisors, Inc.

212.827.0020

jrando@tiberend.com

csojda@tiberend.com

 

SOURCE eNeura Inc.

ADVERTISEMENT

blog comments powered by Disqus

ADVERTISEMENT

Survey
As it creates a plan to implement the US biosimilar pathway, should FDA:
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
Borrow heavily from EMA's pathway program?
88%
Borrow lightly from EMA's pathway program?
4%
Create entirely its own pathway program?
8%
View Results
Untitled Document

Click here