MetaMedical™ Solutions Inc

Zynex’s new NMES device secures FDA clearance

The US Food and Drug Administration (FDA) has approved medical technology company Zynex’s next-generation neuromuscular electrical stimulation (NMES) device, the M-Wave.

This device is intended to aid in the recovery from surgery, manage chronic conditions, and enhance exercise performance.

The M-Wave is set to replace the E-Wave, Zynex’s previous model that has been fundamental in NMES treatments since 1998 across the US.

The E-Wave has been considered a significant device on the market for more than two decades while the M-Wave has a more modern design and comes with additional functionality.

The M-Wave aims to improve the way individuals handle their neuromuscular conditions. It comes with a user-friendly design and advanced features, enabling it to treat patients in a clinical or home setting.

The compact and lightweight design of the device ensures that it is portable and can be easily incorporated into patients’ routines, Zynex said.

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Zynex Medical CEO Thomas Sandgaard said: “The M-Wave introduces the next evolution in NMES devices, allowing for more customisable treatments within clinical and home settings.

“Our product management team has incorporated patient and physician feedback when designing the new M-Wave. The user-friendly interface and ease of use when designing a custom electrotherapy regimen will encourage an even broader adoption of Zynex’s therapeutic products.”

The company submitted a 510(k) application, seeking approval from the FDA for its M-Wave device in November 2023.

Zynex is engaged in the development, manufacturing, marketing and sale of medical devices for pain management and rehabilitation.

It also offers non-invasive fluid, sepsis and laser-based pulse oximetry monitoring systems for use in hospitals.

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