Minneapolis-based Fasikl has obtained FDA 510(okay) clearance for its Felix NeuroAI Wristband for adults with important tremor.
The wearable combines AI and neurotechnology to modulate the nervous system to assist alleviate practical limitations attributable to tremors.
The corporate’s AI repeatedly adjusts stimulation parameters to offer remedy that calms tremors and helps restore motor management.
Fasikl touts that Felix gives aid for each palms, even when the wearer solely has the wristband on one arm, and might help sufferers with gentle, reasonable and extreme tremors.
“We’re coming into an thrilling new chapter, not only for Fasikl, however for the tens of millions of individuals dwelling with important tremor who’ve lengthy been underserved. Our subsequent step is a centered business launch of the Felix NeuroAI Wristband, starting in choose U.S. areas in 2025, with a nationwide rollout deliberate for 2026,” Zhi Yang, CEO of Fasikl, instructed MobiHealthNews in an electronic mail.
“With Felix, we’re pioneering a brand new class of non-invasive, AI-powered remedy that gives actual, day by day aid with out the uncomfortable side effects and dangers of medicine or surgical procedure. That is just the start of what AI can do in neuromedicine, and we’re excited to carry this remedy to the individuals who want it most.”
THE LARGER TREND
Final yr, Fasikl closed a $18.3 million Sequence A+ funding spherical co-led by iSeed and Tailwinds Ventures.
In 2023, Fasikl obtained FDA breakthrough gadget designation for 2 of its choices: MindForce, a nerve-computer interface system designed to permit amputees to manage robotic limbs utilizing their thoughts, and Epione, an providing meant to alleviate post-amputation ache.
That very same yr, the corporate closed a $10 million Sequence A fairness funding spherical, and in 2021, it secured $5 million in pre-Sequence A fairness funding.
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