Microbot Medical Inc. announced on September 30, 2024, an acceleration in patient enrollment for its ACCESS-PVI human clinical trial for the LIBERTY Endovascular Robotic Surgical System. As a result of this increased rate, 80% of the patients have completed their follow-up period, leading the company to anticipate completing the trial earlier than previously expected.
The company confirmed it remains on track to file its 510(k) submission with the U.S. Food and Drug Administration (FDA) by the end of 2024. This accelerated progress in the trial is a significant operational milestone for Microbot Medical.
Additionally, Microbot Medical successfully completed all biocompatibility tests required by its Investigational Device Exemption (IDE) application and received full approval for the IDE study from the FDA. This regulatory clearance is a critical step in advancing the LIBERTY system towards commercialization.
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