MBOT - Microbot announces successful discussions with FDA on regulation of self-cleaning shunt

Microbot Medical ([[MBOT]] +2.3%) announces the completion of successful discussions with the U.S. FDA for its Self-Cleaning Shunt ((SCS)) allowing the company to apply for an Early Feasibility Study ((EFS)).The company reiterates its timeline for the First-in-Human clinical trial under the EFS is expected to start in Q3 2022."The FDA’s response is a significant milestone for our SCS product, as it affirms the novelty of the technology and our pathway as we advance to the next developmental, clinical and regulatory phase,” CEO Harel Gadot said.

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Microbot announces successful discussions with FDA on regulation of self-cleaning shunt