Fasikl has secured FDA 510(k) clearance for its Felix NeuroAI wristband, the first non-invasive wearable designed to treat upper limb tremors in adults with essential tremor.
The device offers a non-surgical alternative to deep brain stimulation by using cloud-connected AI to deliver personalized, adaptive stimulation for all-day symptom relief. Data from the TRANQUIL study showed significant tremor reduction and daily function improvements versus a sham device, with no serious device-related events.
Fasikl plans a limited U.S. launch this year, expanding nationally in 2026. Felix joins Cala Health’s kIQ device in a growing market for wearable tremor therapies.
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