Microbot Medical Inc. has announced that it has filed its pre-submission package for the LIBERTY® Robotic System with the U.S. Food and Drug Administration (FDA), addressing the regulatory pathway for the LIBERTY® Robotic System. This is in line with the Company’s previously stated Q1 timeline. The Company expects to meet with the FDA following a normal review process to discuss the pre-submission and ensure the testing protocols and regulatory pathway are aligned with the FDA to obtain clearance for LIBERTY.
“The significant progress we achieved in the first quarter demonstrates the team is highly focused on delivering key milestones on time,” commented Harel Gadot, Chairman, CEO and President. “The pre-submission filing with the FDA is an important milestone, and although it is the initial phase in the regulatory process, it gives us the confidence to commence implementing plans to scale up the Company’s organizational infrastructure to support future commercial success.”
Source: Microbot Medical.