Tuesday, July 02, 2024
Paradromics Inc., a leading developer of brain-computer interfaces (BCI), has been accepted into the U.S. Food and Drug Administration's Total Product Life Cycle Advisory Program (TAP).
This program, tailored for breakthrough medical devices, aims to accelerate the development and patient access to transformative healthcare technologies.
The FDA has granted Paradromics' Connexus® Direct Data Interface two Breakthrough Device Designations.
These recognize its potential to restore communication for patients who have lost speech and enable computer control for those with severe movement impairment.
These designations facilitate an expedited review process, crucial for devices addressing irreversible and debilitating conditions.
A neurosurgeon from the University of Michigan Medical School, expressed enthusiasm about BCI technologies like Connexus, which are advancing towards clinical application.
This innovation holds promise for restoring movement and speech functions in patients with paralysis and speech loss.
Paradromics distinguishes itself as one of the few companies with fully implantable BCIs capable of single-neuron recording, using durable materials to achieve high-resolution neural data over extended periods.
Initial applications will focus on ALS, spinal cord injury, and stroke patients who have lost communication abilities, with future potential in treatment-resistant mental health conditions such as depression.
The significance of partnering closely with the FDA to ensure the safety and efficacy of their technology. Paradromics' commitment to delivering superior devices through the TAP program's facilitated regulatory pathways.
In preparation for their 2025 clinical trial, Paradromics has launched the Paradromics Patient Registry, enabling potential participants to express interest in upcoming trials.
This initiative aims to foster direct engagement with patients and accelerate the deployment of innovative medical solutions.
Source: prnewswire.com
