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Microbot Medical (MBOT) FDA Events

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FDA Events for Microbot Medical (MBOT)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Microbot Medical (MBOT). Over the past two years, Microbot Medical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as LIBERTY® and LIBERTY®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Microbot Medical's Drugs in FDA Review

LIBERTY® Endovascular Robotic Surgical System - FDA Regulatory Timeline and Events

LIBERTY® Endovascular Robotic Surgical System is a drug developed by Microbot Medical for the following indication: Device Study. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

LIBERTY® Robotic Surgical System - FDA Regulatory Timeline and Events

LIBERTY® Robotic Surgical System is a drug developed by Microbot Medical for the following indication: Device. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Microbot Medical FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Microbot Medical (MBOT) has reported FDA regulatory activity for the following drugs: LIBERTY® Robotic Surgical System and LIBERTY® Endovascular Robotic Surgical System.

The most recent FDA-related event for Microbot Medical occurred on April 9, 2025, involving LIBERTY® Endovascular Robotic Surgical System. The update was categorized as "Data Presentation," with the company reporting: "Microbot Medical Inc presented for the first time the data from its ACCESS-PVI pivotal trial at the Society of Interventional Radiology (SIR) annual meeting."

Current therapies from Microbot Medical in review with the FDA target conditions such as:

  • Device - LIBERTY® Robotic Surgical System
  • Device Study - LIBERTY® Endovascular Robotic Surgical System

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:MBOT) was last updated on 7/11/2025 by MarketBeat.com Staff
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