The pivotal human clinical trial is part of the company’s investigational device exemption application. It will be conducted in the U.S., and Microbot Medical has signed a clinical trial service agreement with “a leading academic medical center.” The company said it is also in the process of engaging more leading medical centers to participate in the trial.

“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,” CEO and President Harel Gadot said in a news release. ”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.”