FDA clearance for AI-powered essential tremor treatment
Smartwatch-looking device offers noninvasive, drug-free alternative to provide all-day relief for essential tremors
July 2, 2025 — University of Minnesota spin-off company Fasikl announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the first-of-its-kind Felix™ NeuroAI™ Wristband for tremor-related functional limitations in the upper limbs in adults with essential tremor.
Headquartered in Minnesota, the neuro-AI company is redefining the intersection of advanced bioelectronic medicine and artificial intelligence (AI). Department of Biomedical Engineering Associate Professor Zhi Yang, who studies emerging brain interface technologies and neuroelectronics, laid the groundwork for a new class of AI-driven therapies and conceptualized Fasikl’s core products and overall business strategy. He co-founded Faskil and serves as the company’s CEO.
“FDA clearance of Felix marks a defining moment for Fasikl and the millions of people living with essential tremor who have long been underserved by existing therapies,” said Yang. “This breakthrough in noninvasive, intelligent, and personalized neuromodulation marks the emergence of AI therapeutics in disease treatment. It offers a new option that is potentially more effective, safer, and more scalable. Our next step is to execute the commercialization plan to support Felix’s initial product launch."