Joint Venture Seeks FDA Designation for MND Device

US-based medtech, Neural Logistics is seeking Humanitarian Use Device designation from the US Food and Drug Administration (FDA) for its brain-computer interface (BCI), designed to restore speech for people with severe paralysis.

Comprised of an implantable electrode inserted into the speech motor cortex region of a patient’s brain, the device measures real-time brains signals and decodes them via algorithms which are then converted into speech.

For now, the FDA designation being sought by Neural Logistics is for use with patients with amyotrophic lateral sclerosis (ALS, the most common form of motor neuron disease) in the United States, with hopes of eventually expanding treatment to people with a range of movement-impairing conditions including locked-in syndrome.

Unlike other BCIs currently available, Neural Logistics said the brain’s neurons grow into the implant, resulting in a more viable, long-term signal.

“I am excited by the prospect of offering immense quality-of-life improvements for ALS and locked-in patients who are currently unable to communicate, despite being cognitively intact,” said Neural Logistics Co-Chief Executive Officer, Dr Philip Kennedy in a press statement.

“Requesting Humanitarian Use Device designation from FDA is a key milestone towards that goal.”

Neural Logistics is a joint venture between pioneering medtech, Neural Signals Inc., and the publicly listed DarkPulse, Inc.

Check out the press statement for further details about the announcement.