Shots:
- The US FDA has granted 510(k) clearance to Felix NeuroAI Wristband for the treatment of essential tremor in the upper limbs of the adults; available in select US states in 2025, with nationwide availability anticipated in 2026
- Clearance was supported by TRANQUIL study assessing Felix wristband vs sham device, which showed reduced tremors & improved ability to perform daily activities in pts, with consistent results across demographics; data was presented at AAN 2025
- Felix NeuroAI Wristband is a non-invasive device that connects to Fasikl’s cloud-based AI platform for continuous brain-AI co-adaptation & personalized therapy through dynamic stimulation to offer all-day symptom relief
Ref: Businesswire | Image: Fasikl| Press Release
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