Microbot Medical Inc. has announced that it has filed an Investigational Device Exemption (IDE) application with the US Food and Drug Administration (FDA). The IDE application follows the completion of multiple preclinical activities performed to provide preliminary safety and effectiveness information, and its approval by the FDA would allow the company to commence its pivotal human clinical trial in the United States.
“This is an important milestone for the company, and it is another step forward in our journey to achieve FDA clearance for the LIBERTY® Endovascular Robotic Surgical System,” said Harel Gadot, CEO, President and Chairman of Microbot Medical.
The Investigational Device Exemption (IDE) application follows the completion of multiple activities necessary to file this application
Source: Microbot Medical Inc.