Tuesday, October 31, 2023
NeuroTrigger is delighted to announce the successful FDA 510(k) clearance for its revolutionary non-invasive muscle stimulation system known as NTB. This clearance is specifically intended for the purpose of preventing or mitigating disuse atrophy and promoting muscle re-education to maintain or enhance range of motion.
The NTB system, which includes a portable, rechargeable stimulator, disposable daily-use electrodes, and a user-friendly mobile app for control, represents a remarkable advancement in the field. Notably, the NTB wearable stimulator is among the most compact and lightweight devices available. Its design allows for precise and customizable muscle stimulation, tailoring parameters to the unique needs of each patient.
This FDA clearance represents a significant achievement as we continue to explore the technology's potential across various clinical applications. Our next steps involve conducting additional clinical trials in both the United States and the United Kingdom to expand the device's approved uses.
One intriguing application we're exploring is the potential use of the NTB system in addressing the needs of patients with facial paralysis. We believe that rhythmic stimulation provided by the NTB system could prove beneficial for improving the range of motion of the orbicularis oculi muscles, potentially facilitating partial eyelid closure. We are eager to undertake the necessary studies to confirm the device's safety and effectiveness for this specific purpose, paving the way for regulatory approvals both within and outside the United States.
Source: prnewswire.com
