The FADLAL -based FDA 510 (K) Statement for its Felix Neuroai poles for adults with essential tremor has received the FDA 510 (K).
The portable combines AI and neurotechnology to modulate the nervous system to help relieve functional limitations caused by tremors.
The AI of the company is constantly adjusting stimulation parameters to offer therapy that calms vibrations and helps to restore motor control.
Fasikl Touts that Felix offers lighting for both hands, even if the wearer only has the wristband on one arm and can help patients with mild, moderate and severe vibrations.
“We are entering an exciting new chapter, not only for Fasikl, but also for the millions of people who live with essential tremor who have been served for a long time. Our next step is a targeted commercial launch of the Felix Neuroai wristband, starting in selected American region MobiHealthNews In an e -mail.
“With Felix we pioneer a new class of non-invasive, AI-driven therapy that offers real, daily lighting without the side effects and risks of medicines or surgery. This is just the start of what AI can do in neuromedicin, and we are enthusiastic to bring this therapy to the people most needed.”
The larger trend
Last year Fasikl closed a Serie A+ Investment Round of $ 18.3 million closed by ISEED and Tailwinds Ventures.
In 2023, Fasikl FDA breakdown equipment designation received for two of its offers: Mindforce, a nerve-computer interfiction system that is designed to enable amputers to control robot-like limbs using their minds, and Epione, an offer that is intended to relieve pain after abuse.
In the same year, the company concluded an investment round of $ 10 million Series A shares and in 2021 the $ 5 million insured in pre-series A stock financing.
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