Muscle fatigue measurement device receives de novo FDA clearance

Muscle fatigue measurement device: ©Myocene

The Belgian sportstech company Myocene announced that its device for providing objective measures of muscle fatigue to inform athletic training decisions by coaches and athletes has obtained a "de novo" FDA clearance.

The portable device, using patented technology, delivers a fatigue index in 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. 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," said Jean-Yves Mignolet, CEO of Myocene, in a statement. "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."

The company has established a US subsidiary, with a dedicated sales team, and the first devices are set to ship in the coming weeks.

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