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NeuroTrigger receives FDA 510(k) for its non-invasive muscle stimulation system
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 atrophy and the re-education of muscles to maintain or increase range of motion.
30/10/2023
The NTB system is wearable, 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 ability to customise the stimulation parameters to the needs of the individual 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 conduct further clinical trials in the US and UK to expand the device's approval 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 may be able to increase the range of motion of the orbicularis oculi muscles to achieve a degree of eyelid closure. We are committed to demonstrating the safety and efficacy of the device for this specific use in order to support regulatory approvals in the US and abroad.
Sales of the NeuroTrigger NTB system are expected to begin in the U.S. next year.
Together with biosaxony, the NeuroTrigger team is already working in parallel on market approval in the EU as part of the MEDICAL FORGE accelerator programme.
Further information can be found at: www.nt-med.com, or visit the official Facebook and LinkedIn channels.
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