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University of Minnesota spin-off receives FDA clearance for AI-powered essential tremor treatment
Smartwatch-looking device offers noninvasive, drug-free alternative to provide all-day relief for essential tremorsMINNEAPOLIS / ST. PAUL (07/02/2025) — 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. University of Minnesota Biomedical Engineering Professor Zhi Yang laid the groundwork for a new class of AI-driven therapies and conceptualized Fasikl’s core products and overall business strategy. Photo by: Fasikl Headquartered in Minnesota, the neuro-AI company is redefining the intersection of advanced bioelectronic medicine and artificial intelligence (AI). University of Minnesota 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 Fasikl 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, who has been a faculty member at the University of Minnesota since 2015. “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."According to previous research, essential tremor is the most common type of tremor disorder, affecting about 7 million people in the United States and is about seven times more common than Parkinson’s disease. It causes involuntary and rhythmic shaking—most often in the hands—that can make simple and everyday activities like drinking from a glass or tying shoelaces difficult. Traditional treatment options are limited, with oral medications providing inconsistent relief and often accompanied by undesirable side effects. Surgical interventions such as deep brain stimulation (DBS), while effective, require invasive procedures, carry surgical risks, and may not be suitable or desirable for all patients, particularly older adults or those with coexisting health conditions.Unlike interventions using surgeries or medicines, Felix is a noninvasive, wearable device that effortlessly connects to Fasikl’s cloud-based AI platform, enabling continuous brain-AI co-adaptation and personalized therapy. Worn on the wrist, it uses the cloud to dynamically adjust stimulation, offering all-day symptom relief while seamlessly fitting into the wearer’s lifestyle.The FDA clearance of Felix is supported by data from the TRANQUIL study, a randomized, double-blind, sham-controlled trial. Results showed that the Felix wristband significantly reduced tremors and displayed statistically and clinically significant improvement in the users' ability to perform daily activities compared to those using a device that looked similar but provided no real therapy. Efficacy was consistent across demographics, with no serious device-related adverse events reported. Results of this study were presented at the American Academy of Neurology annual meeting in April 2025.“The Felix wristband represents a significant step forward in noninvasive, personalized treatment options for essential tremor,” said Rajesh Pahwa, M.D., a Laverne and Joyce Rider Professor of Neurology at the University of Kansas School of Medicine, Director of the Movement Disorder Program at The University of Kansas Health System. “For many patients, current treatment options fall short — pharmaceutical treatments are helpful for less than 50 percent of the patients, and deep brain stimulation and focused ultrasound, while effective, require surgical intervention. This new AI wearable wristband backed by clinical evidence is an effective treatment option in patients with essential tremor.”The Felix NeuroAI Wristband will be available by prescription through healthcare providers in select U.S. regions starting later this year, with nationwide availability expected in 2026.To learn more, visit the Fasikl website.
