Healthcare Industry News: FDA
News Release - February 6, 2024
Zynex Receives FDA Clearance for its Next Generation NMES Device
ENGLEWOOD, Colo., Feb. 6, 2024 -- (Healthcare Sales & Marketing Network) -- Zynex, Inc. (NASDAQ: ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, today announced that it has received clearance from the U.S. Food and Drug Administration ("FDA") for the next generation M-Wave Neuromuscular Electrical Stimulation ("NMES") device.NMES treatments have several uses, including aiding recovery from surgery, managing chronic conditions, and even enhancing exercise performance in healthy individuals.
The M-Wave replaces its predecessor, the E-Wave, which has been fundamental in NMES treatments across the U.S. since 1998. The E-Wave was the most powerful and versatile muscle stimulation device on the market for over two decades and the M-Wave builds on that history of performance with a more intuitive design and additional functionality.
"The M-Wave introduces the next evolution in NMES devices, allowing for more customizable treatments within clinical and home settings," said Thomas Sandgaard, CEO at Zynex Medical. "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 M-Wave is designed to improve the way patients manage their neuromuscular conditions. With advanced features and a user-friendly design, the M-Wave allows patients to be treated quickly in a clinical or home setting. The compact and lightweight design of the M-Wave ensures portability and easy integration into patients' recovery routines.
About Zynex, Inc.
Zynex, founded in 1996, develops, manufactures, markets, and sells medical devices used for pain management and rehabilitation as well as non-invasive fluid, sepsis, and laser-based pulse oximetry monitoring systems for use in hospitals. For additional information, please visit: www.zynex.com.
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These and other risks are described in our filings with the Securities and Exchange Commission including but not limited to, our Annual Report on Form 10-K for the year ended December 31, 2022 as well as our quarterly reports on Form 10-Q and current reports on Form 8-K. Any forward-looking statements contained in this press release represent Zynex's views only as of today and should not be relied upon as representing its views as of any subsequent date. Zynex explicitly disclaims any obligation to update any forward-looking statements, except to the extent required by law.
Source: Zynex
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