Surgical Robot Company Applies for FDA Approval

Microbot Medical, a medical device company creating micro-robotic surgical systems, has filed an Investigational Device Exemption (IDE) application with the U.S. Food and Drug Administration (FDA) for its Liberty Endovascular Robotic Surgical System.

The application follows the successful completion of preclinical tests, demonstrating the system's safety and efficacy. FDA approval would allow Microbot to progress its system to human clinical trials in the U.S.

“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, Microbot Medical’s CEO.

Endovascular surgeries target a patient’s blood vessels and by creating a minimally invasive and easily maneuverable system is an important step to improving procedures for both patients and health care professionals.

Microbot said its system eliminates the need for large, cumbersome and expensive capital equipment, and can also reduce radiation exposure and physician strain. 

The company also said it hopes to improve access to robotic surgical devices, with Liberty’s remote capabilities potentially making it the “first system to democratize endovascular interventional procedures.”

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In January, the company expanded its U.S. operations ahead of the now-filed IDE application, as it prepared for its next steps to commercialization.

“Following the successful completion of our pivotal GLP preclinical trial, and as we are in the final stage of submitting our IDE,” Juan Diaz-Cartelle, chief medical officer of Microbot Medical, said at the time. “Having an in-house clinical research associate is a key piece for establishing the right infrastructure for clinical trial execution.”