University of Minnesota spinout Fasikl has obtained an FDA clearance for its artificial-intelligence-powered wearable for people with essential tremor.
The company’s Felix NeuroAI Wristband aims to provide personalized stimulation therapy based on real-time feedback to help interrupt the involuntary shaking that can occur in the hands—a disorder that affects about 7 million people in the U.S., according to Fasikl, or is about seven times more common than Parkinson’s disease.
“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.”
The company said the prescription, cloud-connected wristband will start with a limited U.S. rollout this year before pursuing plans to go nationwide in 2026.
This past April, Fasikl put forward clinical data from a pivotal, sham-controlled trial showing the device significantly reduced tremors and improved its user’s ability to perform daily activities.
The trial, which enrolled 125 participants in the U.S. and China, also demonstrated that efficacy benefits after 90 days were consistent across users’ age, gender, tremor severity and medication use, the company said. The results were presented as a late-breaking study at the annual meeting of the American Academy of Neurology.
Last September, Fasikl said it raised $18.3 million in venture capital funding—co-led by iSeed and Tailwinds Ventures—as an addition to its March 2023 series A round, which initially collected $10 million.
The company, which launched in 2019, is also developing Fasikl-X as a nerve-computer interface aimed at operating prosthetic limbs.