TMS technology is not new and other devices have been approved using the same/similar 
technology. As I understand you do a prescription to get the device and anyone with a pace maker or other metals in their body are out of luck simply due to the way the device works. Here’s another example of the technology that received an FDA approval not too long ago and it’s much more complex obviously and not one you use at home.
Brainsway Deep TMS (transcranial magnetic stimulation)Gets FDA Approval for the Treatment of Depression
The video below from a talk show in the UK from last year explains how it works and it looks simple enough as far as just holding the device across the back of your head. A neurologist talks about why and how and why it works.
The effort of course is to bring a limit to the amount of “pills” taken to get relief, pain killers of course being one that comes to mind. You can read more at the Eneura web site. When one feels a headache coming on you get the device and begin treatment right away. The treatment is automatically recorded and it creates a journal all interactions with the device and it can be shared with a doctor. BD
The US Food and Drug Administration has granted marketing approval for eNeura Therapeutics' Cerena Transcranial Magnetic Stimulator (TMS), the first device to relieve pain caused by migraine headaches that are preceded by an aura: a visual, sensory or motor disturbance immediately preceding the onset of a migraine attack.
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.
A migraine can last anywhere between four and 72 hours when untreated. These debilitating headaches affect approximately 10 per cent of people worldwide and are three times more common in women than in men. About one third of people with migraines experience an aura.
“Millions of people suffer from migraines and this new device represents a new treatment option for some patients,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.
The Cerena TMS is a prescription device used after the onset of pain associated with migraine headaches preceded by an aura. Using both hands to hold the device against the back of the head, the user presses a button to release a pulse of magnetic energy to stimulate the occipital cortex in the brain, which may stop or lessen the pain associated with migraine headaches preceded by an aura.
Patients must not use the Cerena TMS device if they have metals in the head, neck, or upper body that are attracted by a magnet, or if they have an active implanted medical device such as a pacemaker or deep brain stimulator. The Cerena TMS device should not be used in patients with suspected or diagnosed epilepsy or a personal or family history of seizures. The recommended daily usage of the device is not to exceed one treatment in 24 hours.
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