Minneapolis-based Fasikl has received FDA 510(k) clearance for its Felix NeuroAI Wristband for adults with essential tremor.
The wearable combines AI and neurotechnology to modulate the nervous system to help alleviate functional limitations caused by tremors.
The company's AI continuously adjusts stimulation parameters to provide therapy that calms tremors and helps restore motor control.
Fasikl touts that Felix provides relief for both hands, even if the wearer only has the wristband on one arm, and can help patients with mild, moderate and severe tremors.
"We're entering an exciting new chapter, not just for Fasikl, but for the millions of people living with essential tremor who have long been underserved. Our next step is a focused commercial launch of the Felix NeuroAI Wristband, beginning in select U.S. regions in 2025, with a national rollout planned for 2026," Zhi Yang, CEO of Fasikl, told MobiHealthNews in an email.
"With Felix, we're pioneering a new class of non-invasive, AI-powered therapy that offers real, daily relief without the side effects and risks of drugs or surgery. This is just the beginning of what AI can do in neuromedicine, and we're excited to bring this therapy to the people who need it most."
THE LARGER TREND
Last year, Fasikl closed a $18.3 million Series A+ investment round co-led by iSeed and Tailwinds Ventures.
In 2023, Fasikl received FDA breakthrough device designation for two of its offerings: MindForce, a nerve-computer interface system designed to allow amputees to control robotic limbs using their mind, and Epione, an offering intended to alleviate post-amputation pain.
That same year, the company closed a $10 million Series A equity investment round, and in 2021, it secured $5 million in pre-Series A equity funding.
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