FDA Clears Fasikl's AI-Powered Wristband for Essential Tremor

University of Minnesota spinout Fasikl has received FDA clearance for its artificial intelligence-powered wearable designed to treat essential tremor. The Felix NeuroAI Wristband represents a new approach to managing involuntary hand shaking that affects approximately 7 million people in the United States—about seven times more common than Parkinson's disease.

The prescription, cloud-connected device delivers personalized stimulation therapy based on real-time feedback to help interrupt tremors. The wristband uses noninvasive neuromodulation technology that adapts to each user's specific needs through AI algorithms.

"This breakthrough in noninvasive, intelligent, and personalized neuromodulation marks the emergence of AI therapeutics in disease treatment," CEO Zhi Yang, Ph.D., said in a statement. "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."

Clinical validation for the device came from a pivotal, sham-controlled trial involving 125 participants across the United States and China. The study, presented as a late-breaking presentation at the American Academy of Neurology's annual meeting in April, demonstrated that the Felix NeuroAI Wristband significantly reduced tremors and improved users' ability to perform daily activities.

The trial results showed consistent efficacy benefits after 90 days of use, regardless of participants' age, gender, tremor severity or medication use. This broad effectiveness across different patient demographics suggests the device could serve as a viable treatment option for diverse essential tremor populations.

Fasikl plans to begin with a limited U.S. rollout this year before expanding nationwide in 2026. The phased approach will allow the company to refine its commercialization strategy while gathering real-world data on device performance and user experience.

The company has secured significant financial backing to support its launch plans. In September, Fasikl raised $18.3 million in venture capital funding co-led by iSeed and Tailwinds Ventures. This funding supplemented the company's March 2023 series A round, which initially raised $10 million.

Founded in 2019, Fasikl is also developing additional neurotechnology applications beyond essential tremor. The company is working on Fasikl-X, a nerve-computer interface designed to operate prosthetic limbs, demonstrating its broader commitment to advancing neural interface technologies for various medical applications.

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