NeuroTrigger is pleased to announce that its non-invasive muscle stimulation system (NTB) has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for the prevention or slowing of muscle wasting and muscle re-education Maintaining or increasing range of motion.
The NTB system is portable, rechargeable, aesthetic and user-friendly and consists of three elements: a stimulator, a disposable electrode for daily use and a mobile app that controls the system. The NTB Wearable Stimulator is one of the smallest and lightest stimulators on the market. The NTB system is designed to stimulate the muscles in a controlled rhythm, with the possibility of adapting the stimulation parameters to the needs of each patient.
Dr. Nikolai Kunicher, CEO of NeuroTrigger, commented: “This FDA milestone is important as we develop the technology for various clinical applications. From here, we will continue to conduct clinical trials in the US and UK to expand the device's regulatory claims. For example, the device has the potential to address an unmet need in patients with facial paralysis, where the rhythmic stimulation provided by the NTB system could be suitable for increasing the range of motion of the orbicularis oculi muscles to achieve a certain degree of eyelid closure. We are committed to demonstrating the safety and effectiveness of the device for this specific use to support regulatory approvals within and outside the United States.
Sales of the NeuroTrigger NTB system are expected to begin in the United States next year.
The NeuroTrigger team works together with biosaxony as part of the accelerator program MEDICAL FORGE At the same time, it is already working on market approval in the EU.
For more information, please visit: www.nt-med.com, or visit the official ones Facebook- and LinkedIn channels.
Source: Press release NeuroTrigger from October 30.10.2023, XNUMX