Establishment Labs Holdings (NASDAQ:ESTA) has announced a pivotal development in its quest for U.S. market approval of its Motiva Implants.

According to a recent filing with the Securities and Exchange Commission (SEC), the U.S. Food and Drug Administration (FDA) has slated a pre-approval inspection of the company's manufacturing facilities for the second quarter of 2024.

This scheduled inspection marks a crucial milestone in Establishment Labs' regulatory journey, potentially paving the way for the approval of Motiva Implants in the United States.