An FDA review panel recently voted 11-0 to recommend approval for the cutting edge NeuroPace RNS system—a neuromodulation device for treatment-resistant epilepsy in patients with partial onset seizures.
NeuroPace will hear back from the FDA on final approval in the next few months, but the panel’s endorsement marks a huge step forward for the 30% of epilepsy patients who don’t respond to medication. If the RNS system is approved as expected, it will become the first new epilepsy device in the U.S. since the vagus nerve stimulator (VNS) was approved over 15 years ago.
FDA panel recommends new epilepsy device: First in 15 years
Brainsway Ltd. has received FDA approval for the use of their Deep TMS (transcranial magnetic stimulation) system to treat drug-refractory depression, becoming only the second company to win the rights to sell TMS devices in the U.S.
Cutting edge depression treatment faces new competition
Now that we are nearly a month into 2013, it’s time to reset our horizon scanning efforts and prepare ourselves for the year ahead. Last year was exciting for the neurosciences community. Several artificial discs and stroke devices were approved by the FDA, the debate about the efficacy of spine surgery continued, and new criteria for comprehensive stroke center certification was released.
It’s easy to imagine that 2013 will come with a host of new technological and programmatic developments across the year. To help understand the evolving product pipeline in neurosciences and spine, I've outlined what we believe are the top six technological trends to watch for across 2013.
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What to watch for in neurosciences in 2013: New devices target specialized conditions