Breakthrough technology for human muscle fatigue measure, Myocene, gets FDA “de novo” approval.

MYOCENE kicks off the first FDA De Novo clearance of 2025 for its groundbreaking muscle fatigue monitoring device.

LIÈGE, Belgium, Jan. 30, 2025 /PRNewswire/ — Myocene, the Belgian sportstech company specializing in innovative muscle fatigue assessment announced today that its groundbreaking device for “providing objective measures of muscle fatigue to inform athletic training decisions by coaches and athletes” obtained a “de novo” FDA clearance.

Using patented and unique technology, this portable device delivers a fatigue index in just two minutes, empowering athletes and coaches to make smarter, data-driven training decisions—whether indoors or outdoors. The device combines high-precision electrostimulation and force measurement to obtain this fatigue index. There is no equivalent on the market. Myocene works with many top sports teams around the world, and in different disciplines (athletics, handball, skiing, soccer, ultra trail, etc.).

“FDA’s clearance marks a pivotal step towards the broader adoption of our technology,” declares Jean-Yves Mignolet, CEO of Myocene. “Following significant traction in the European market– including use by several top football (soccer) clubs — this clearance opens the US professional sports market, where the first customers have eagerly awaited the opportunity to order. Very soon, you’ll begin to see elite athletes using the Myocene device as part of their training and performance strategies.”

To meet anticipated demand, Myocene has established a US subsidiary, with a dedicated sales team. The first devices are set to ship in the coming weeks.

About Myocene
Founded in 2020 and headquartered in Liège, Belgium, Myocene is a leader in medical and sports technology. The company’s innovative device for measuring muscle fatigue bridges the critical gap in athletic performance management and injury prevention. The game-changing technology, validated by sports physiologist Prof. Guillaume Millet (Jean Monnet University, France), has been tested by more than 1,800 athletes and is already trusted by leading European sports organizations. Beyond sports, the device also offers promising applications in occupational medicine and the treatment of muscle pathologies.

Contacts
Jonathan Saul, Media Contact
press@myocene.com
+1 (800) 410-9718

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SOURCE Myocene