Fasikl announced that it received FDA 510(k) clearance for its first-of-its-kind NeuroAI wristband for essential tremor.
Felix NeuroAI treats tremor-related functional limitations in the upper limbs in adults with essential tremor. Minneapolis-based Fasikl designed its device as an alternative to interventions like deep brain stimulation (DBS) that require invasive procedures.
The non-invasive, wearable device connects to Fasikl’s cloud-based AI platform. It enables continuous brain-AI co-adaptation and personalized therapy. While worn on the wrist, the device uses the cloud to dynamically adjust stimulation. Fasikl says it offers all-day symptom relief while also fitting into the wearer’s lifestyle.
According to Fasikl, data from its TRANQUIL study supported the FDA clearance for Felix. 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 sham device. The study also saw consistent efficacy across demographics with no serious device-related adverse events reported.
Fasikl plans to launch the wristband by prescription in select U.S. regions this year, followed by nationwide availability in 2026. Felix could add competition to the essential tremor treatment market, which also features the Cala kIQ wrist-worn device launched in 2023. kIQ delivers transcutaneous afferent patterned stimulation (TAPS) therapy for treating tremor.
“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 Zhi Yang, CEO of Fasikl. “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.”
