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Microbot Medical Announces Successful Outcome of its Discussions with FDA Regarding Regulation of Self-Cleaning Shunt


Microbot Medical Announces Successful Outcome of its Discussions with FDA Regarding Regulation of Self-Cleaning Shunt
Microbot Medical Announces Successful Outcome of its Discussions with FDA Regarding Regulation of Self-Cleaning Shunt
HINGHAM, Mass., Jan. 27, 2021 Microbot Medical Inc. (Nasdaq: MBOT) announced the completion of successful discussions with the U.S. Food and Drug Administration (FDA) for its Self-Cleaning Shunt (SCS). After review of the Company’s existing pre-clinical data, the FDA’s feedback will allow the Company to apply for a limited clinical investigation known as an Early Feasibility Study (EFS), which is designed for novel technologies such as the SCS. Consequently, the Company reiterates its timeline for the First-in-Human (FIH) clinical trial under the EFS, expected to commence in the third quarter of 2022. ....

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