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DarkPulse JV Neural Logistics files for FDA Humanitarian Use Device designation for speech prosthesis
DarkPulse, Inc.
- Neural Logistics, DarkPulse JV, seeks FDA Humanitarian Use Device designation for speech prosthesis for ALS patients.
- Machine learning algorithms decoded rat brain signals with >95% accuracy, enabling speech-from-thought approach.
- NXNE electrode has been used successfully for 13 years in a locked-in patient with no signal deterioration.
- Technology aims to restore speech in cognitively intact individuals with ALS, locked-in syndrome, and other impairments.
- Co-CEO Dr. Phil Kennedy calls FDA designation a key milestone toward implanting locked-in patients.