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Neurotech startup Neurovalens gets FDA clearance for noninvasive anxiety treatment
A 2019 rule-change by the US medical devices regulator aimed at encouraging innovations targeting insomnia and anxiety is bearing fruit: Neurovalens, a Neurovalens, a Belfast-based startup that's been developing technology to deliver non-invasive electrical stimulation of the brain and nervous system for almost a decade, has had its second head-mounted treatment device cleared by the FDA.
This pathway requires it to conduct clinical trials to demonstrate significant results for particular use-cases — i.e. rather than going direct to consumers with a marketing pitch comprised of fuzzier ‘well-ness’ promises — but it’s a differentiating strategy, per McKeown. Neurovalens’ products take the form of a head-mounted device that applies electrical neurostimulation to the skin behind the ear — directly targeting the vestibular nerve — as a route to stimulate the hypothalamus and associated autonomic nuclei of the brainstem. The vestibular system is typically associated with balance but McKeown suggests it’s been underestimated — saying it plays a critical role in “overall homeostasis”; helping regulating everything from blood pressure to breathing rate, heart beat or even how much fat the body stores.
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