SciBase submits application for pre-market approval to FDA
The U.S. Food and Drug Administration (FDA) has confirmed that the organization has received SciBase’s application for a pre-market approval (PMA) of the Nevisense device for the US market.“We have been working with the clinical studies and documentation that the FDA requires for several years. It has been a long process that culminated in the completion of the application during this quarter. The US market is the world’s largest and represents a significant opportunity for SciBase. Even a limited penetration of our method and Nevisense has the possibility to transform our business”, says