A (Small) Step Closer to a TMS Device for U.S. Migraineurs
eNeura, the company that made the Cerena transcranial magnetic stimulation (TMS) device, has taken one more step toward making TMS available to U.S. patients by completing a filing requirement with the FDA.
Woo hoo! A company did some paperwork. What’s the big deal?
With this filing, eNeura has officially told the FDA that a new device (called SpringTMS), based on the recently approved Cerena, is in the works. In other words, SpringTMS is not only happening, but the company has started moving toward FDA approval.
Still wondering why I’m telling you this? In a press release, eNeura’s president says that the company is “optimistic that the SpringTMS will launch in 2014.” Now, “launch” is pretty vague. It could mean that the device will be available to patients in 2014. It could also mean that the final FDA approval process will get underway. Or maybe that the pilot study will begin. Whatever the president truly meant, my fingers are crossed that my cynical prediction of availability to patients in January 2016 is overly negative.
For many of you, this bit of news doesn’t mean anything at all. For those who are desperately awaiting the availability of a TMS device in the U.S., even a little step forward is progress.