FDA Authorizes Myocene Device for Muscle Fatigue Monitoring and Informed Training Decisions

LIÈGE, Belgium, Jan. 27, 2025 (GLOBE NEWSWIRE) — Myocene, the Belgian sportstech company specializing in innovative muscle fatigue assessment for top-level athletes announced today that the US Food and Drug Administration (FDA) has granted authorization for its groundbreaking device, “intended to provide objective measures of muscle fatigue to inform athletic training decisions by coaches and athletes”.

The clearance was obtained following a de novo procedure, reserved to innovative low-risk devices for which there is no predicate device on the market. Myocene’s device provides a disruption in the way fatigue and recovery can be assessed and monitored, enabling strength and conditioning coaches to optimize training plans with unprecedented precision.

Cutting-Edge Technology for Precision and Portability

Myocene’s unique patented technology relies on decades of scientific research and combines high precision electrostimulation and force sensing to obtain a fatigue index in just two minutes. Tailored for field use, the device operates seamlessly both indoors and outdoors.

“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