Paradromics inches closer to FDA approval for brain implant

New York: US-based brain-computer interface developer Paradromics may be a step closer to getting the Food and Drug Administration (FDA) approval for its brain implant that can help severely motor-impaired people, the company has announced.

The company, in a statement, said that the US regulator has granted the implant a “breakthrough device designation” for its Connexus Direct Data Interface (DDI).

The designation offers an expedited review process for transformative medical devices with the potential to treat irreversibly debilitating conditions.

Connexus DDI is an assistive communication device that translates brain signals into speech and movement in real time, restoring social connection and enabling independent engagement with technology. As it records directly from the brain, the neuroprosthesis could restore communication and functional independence to thousands of people living with paralysis.

“This designation recognises the transformative promise of our device, and we look forward to continued coordination with the FDA to accelerate its availability,” said Paradromics CEO Matt Angle, in the statement.

Meanwhile, the company also announced a $33 million Series A funding round led by Prime Movers Lab and Westcott Investment Group, Dolby Family Ventures, and Green Sands Equity.AA

“This investment validates our leadership position among the small group of BCI platform companies on the verge of commercialisation,” Angle said

Paradromics is part of the emerging brain-computer interface, or BCI, industry. Beyond assistive communication, BCI has the potential to address a range of currently unmet medical needs, from motor and sensory deficits to chronic pain and mood disorders.

The best-known name in the BCI space is billionaire Elon Musk’s Neuralink.

While Neuralink is focussed more on neurological disorders, the potential applications of Paradromics implant are far-reaching and diverse.

The Connexus DDI can help people with conditions like ALS, spinal cord injury, and stroke which causes severe motor impairment, affecting patients’ ability to communicate. Many of these patients have intact, highly active brains but may struggle to speak or use a computer or rely on slow, frustrating gaze-tracking systems.

The technology could revolutionise the treatment of neurological and brain-related conditions ranging from sensory deficits to mood disorders.

(IANS)