FDA Clears AI Wristband for Essential Tremor Therapy US-Wide

The FDA has approved the Felix NeuroAI Wristband, a noninvasive, AI-powered wearable device developed by Fasikl to treat upper limb functional limitations in adults with essential tremor, a movement disorder affecting approximately 7 million people in the U.S. The wristband delivers personalized neurostimulation therapy by continuously adjusting stimulation through a cloud-based AI platform, offering a safer and more scalable alternative to pharmaceutical treatments and invasive surgical options like deep brain stimulation. Clinical data from the TRANQUIL study, involving 125 participants in the U.S. and China, demonstrated significant reductions in tremors and improved ability to perform daily activities compared to a sham device, with consistent efficacy across demographics and no serious adverse events. Fasikl plans a limited U.S. rollout of the prescription device in 2025, with nationwide availability expected in 2026. Experts highlight that this device represents a major advance in personalized, intelligent neuromodulation and AI therapeutics for essential tremor, addressing the unmet needs of patients who have limited effective treatment options. Fasikl also aims to expand its AI-driven platform to other applications, including nerve-computer interfaces for prosthetic limb operation.