Microbot Medical Gets FDA OK to Proceed with Pivotal Trial

Microbot Medical has gained U.S. Food and Drug Administration (FDA) approval to proceed with its pivotal trial as part of its investigational device exemption (IDE) application for its Liberty endovascular robotic surgical system.
 
The study will be done in the U.S. and the company said it has signed a clinical trial service agreement with a “leading academic medical center.” Microbot also said it’s currently engaging further leading centers for the trial.
 
In parallel to beginning the trial, the company is completing the biocompatibility tests required by its IDE application.
 
“The recent authorization by the FDA to commence our pivotal clinical study, following submission of the results of our extensive pre-clinical studies and tests, reinforces our confidence in our innovative technology,” said Harel Gadot, Microbot Medical’s chairman, president, and CEO. ”It is also a testament to our commitment to meet meaningful milestones as we continue our path towards potential regulatory clearance and subsequent commercialization in the US and other regions across the globe”.

More about the Liberty robot

The investigational Liberty endovascular robotic surgical system aims to improve how surgical robotics are used in endovascular procedures.
 
The system aims to remove the need for large, cumbersome, and expensive capital equipment. It also aims to reduce radiation exposure and physical strain. Microbot believes Liberty’s remote operation could be the first system to democratize endovascular interventional procedures.
 
Earlier this year, the company released positive outcomes from its pivotal pre-clinical study using the Liberty system. Microbot also welcomed a new chief medical officer in February 2024.