This NTB system is designed to stimulate muscles in a controlled rhythm with an option to personalize the stimulation parameters for each patient's needs.
NeuroTrigger Received FDA 510(k) for its non-invasive muscle stimulation system (NTB). (Credit: Alexander Jawfox on Unsplash)
NeuroTrigger is pleased to announce that its non-invasive muscle stimulation system (NTB) has been granted 510(k) clearance by the US Food & Drug Administration (FDA) for the prevention or retardation of disuse atrophy and muscle re-education to maintain or increase range of motion. The NTB system is portable, rechargeable, aesthetic, and user-friendly and is composed of 3 elements: a stimulator, a daily use /disposable electrode, and a mobile App., which controls the system. The NTB wearable stimulator is one of the smallest and lightweight stimulators available. This NTB system is designed to stimulate muscles in a controlled rhythm with an option to personalize the stimulation parameters for each patient’s needs.
Dr Nikolai Kunicher, NeuroTrigger CEO commented that “This FDA milestone is important as we develop the technology for different clinical applications. From here, we will be performing additional clinical trials in U.S. and U.K. to extend the labeling claims of the device. For example, the device has the potential to serve an unmet need in patients suffering from facial paralysis whereby rhythmic stimulation by the NTB system may be suitable for use to increase the range of motion of the orbicularis oculi muscles to achieve some degree of eyelid closure. We are eager to establish the safety and effectiveness of the device for this specific intended use to support regulatory clearances inside and outside the U.S.”
Source: Company Press Release