PRISM MedDevice Mover Microbot (MBOT) Up ~98% on FDA Approval For Human Clinical Trial

The PRISM MedDevice Index company and the developer of the innovative LIBERTY® Endovascular Robotic Surgical System, Microbot Medical (MBOT) has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to proceed with its pivotal human clinical trial under its Investigational Device Exemption (IDE) application for the LIBERTY® system.

The study will take place in the United States, with the company having already signed a clinical trial service agreement with a leading academic medical center. Additionally, efforts are underway to engage other prominent centers to join the trial.

Concurrently, the company is finalizing its biocompatibility tests as required by the IDE application.

“The recent FDA authorization to commence our pivotal clinical study, following the submission of our extensive pre-clinical studies and tests, reinforces our confidence in our innovative technology,” stated Harel Gadot, CEO, President, and Chairman. “It also underscores our commitment to achieving significant milestones as we progress towards potential regulatory clearance and subsequent commercialization in the US and other regions worldwide.”