Tibion has developed the PowerKnee, a wearable bionic device for the leg which actively and transparently supplements muscle strength.
To achieve licensure, Tibion demonstrated compliance with the federal good manufacturing practice/quality system regulation as part of a rigorous audit conducted by the State of California Food & Drug Branch (FDB).
This regulation governs the requirements for a comprehensive management system for the design and manufacture of medical devices. The FDB works in partnership with the FDA to regulate medical devices in California.
Kern Bhugra, CEO of Tibion, said: “Tibion has reached another milestone in our goal towards commercializing the PowerKnee. We are committed to providing high quality products to assist patients dealing with the loss of muscle function.”