Myocene Gains FDA De Novo Nod for Muscle Fatigue Measure Tech

Myocene, a Belgian sports tech company specializing in muscle fatigue assessment, has received U.S. Food and Drug Administration (FDA) de novo clearance for its device to provide objective measures of muscle fatigue to inform athletic training decisions by coaches and athletes.

The device delivers a fatigue index in two minutes so athletes and coaches can make data-driven training decisions, indoors or outdoors. It combines electrostimulation and force measurement to obtain the fatigue index.

Myocene said it works with top sports teams around the world in different disciplines, including athletics, handball, skiing soccer, ultra trail, and more. The company also said there’s no equivalent to its technology on the market.

To meet its expected demand, the company established a U.S. subsidiary with a dedicated sales team. The first devices are anticipated to ship in the weeks to come.

“FDA’s clearance marks a pivotal step towards the broader adoption of our technology,” said 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.”

Beyond sports, the company said the device offers promising applications in occupational medicine and treatment of muscle pathologies.