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.
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.
- Drug:
- LIBERTY® Endovascular Robotic Surgical System
- Announced Date:
- April 9, 2025
- Indication:
- Device Study
Announcement
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.
AI Summary
Microbot Medical Inc. presented data from its ACCESS-PVI pivotal trial at the Society of Interventional Radiology (SIR) annual meeting. The trial, carried out at three major U.S. medical centers, showed a 100% success rate in robotic navigation during endovascular procedures with the LIBERTY® Robotic System. This achievement met the study's primary endpoint while also reporting a significant reduction in radiation exposure—92% less compared to conventional methods.
During the trial, no adverse device events occurred, and participating physicians noted that the system performed as expected with high satisfaction. The results provide promising evidence of the LIBERTY® system's potential to improve procedural outcomes and safety. The data presentation marks an important milestone for Microbot Medical Inc. as it prepares to expand its commercial capabilities.
Read Announcement- Drug:
- LIBERTY® Endovascular Robotic Surgical System
- Announced Date:
- February 4, 2025
- Estimated Event Date Range:
- April 2, 2025 - April 2, 2025
- Target Action Date:
- April 2, 2025
- Indication:
- Device Study
Announcement
Microbot Medical Inc. announced the acceptance of a late-breaking abstract that will be presented at the upcoming Society of Interventional Radiology (SIR) annual meeting, being held in Nashville, TN on March 29 - April 2, 2025.
AI Summary
Microbot Medical Inc. announced that its late-breaking abstract has been accepted for presentation at the upcoming Society of Interventional Radiology (SIR) annual meeting in Nashville, TN from March 29 to April 2, 2025. The presentation will highlight key data from the ACCESS-PVI trial, a study designed to evaluate the safety and performance of the LIBERTY® Endovascular Robotic System during peripheral vascular interventions.
Scheduled for Wednesday, April 2, at Music City Center, the abstract titled “Remote-controlled endovascular navigation with a miniature, single-use, robotic system” will be presented at the podium. The research is expected to attract significant interest from potential users of LIBERTY® as the findings suggest meaningful improvements in robotic-assisted vascular procedures. Microbot Medical believes that sharing these promising results will further demonstrate the benefits of their innovative, single-use robotic system in advancing patient care.
Read Announcement- Drug:
- LIBERTY® Endovascular Robotic Surgical System
- Announced Date:
- December 30, 2024
- Indication:
- Device Study
Announcement
Microbot Medical Inc. concludes 2024 with the achievement of several key milestones, including the recent FDA 510(k) submission for FDA commercial approval of LIBERTY®, which the company believes will position the Company for continued success in 2025.
AI Summary
Microbot Medical Inc. ended 2024 on a high note by achieving several key milestones. Among these, the company recently submitted a FDA 510(k) file for commercial approval of its LIBERTY® Endovascular Robotic System. This important submission is designed to pave the way for LIBERTY’s anticipated launch in the U.S. during Q2 2025. The FDA filing signals a significant move toward the commercialization of a single-use, fully disposable robotic system that aims to improve patient care and simplify access to advanced endovascular technology. Microbot Medical believes that this regulatory milestone, along with ongoing preparations and strategic initiatives, positions the company strongly for continued success in 2025 and beyond. The achievement underscores the firm’s commitment to innovation and its focused efforts to bring transformative medical technology to market.
Read Announcement- Drug:
- LIBERTY® Endovascular Robotic Surgical System
- Announced Date:
- August 13, 2024
- Indication:
- Device Study
Announcement
Microbot Medical Inc. announces it has received ISO 13485:2016 certification for its quality management system.
AI Summary
Microbot Medical Inc. has received ISO 13485:2016 certification for its quality management system. This achievement shows the company has implemented strong policies and procedures for developing and manufacturing regulated medical products. The ISO 13485 standard is made for the medical industry and focuses on proper risk assessment and effective process management. By meeting these requirements, Microbot Medical proves that it consistently reviews and validates its product development and manufacturing processes, ensuring quality and traceability across operations.
Noa Ofer, PhD, Sr. Director of Quality Assurance and Regulatory Affairs, stated that the extensive audit process is a testament to the company’s efforts as it moves toward commercialization. The certification also supports the company’s compliance with European requirements under the Medical Device Regulation and helps streamline its transition into revised FDA regulations.
Read Announcement
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.
- Drug:
- LIBERTY® Robotic Surgical System
- Announced Date:
- December 10, 2024
- Indication:
- Device
Announcement
Microbot Medical Inc. announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for LIBERTY®.
AI Summary
Microbot Medical Inc. announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its LIBERTY® Endovascular Robotic System. The innovative system is the world’s first single-use, fully disposable robotic solution designed for endovascular procedures. This submission comes on the heels of a successful multi-center, single-arm human clinical trial, which confirmed the safety and performance of LIBERTY® during peripheral vascular interventions.
The company anticipates that the FDA will grant marketing clearance in the second quarter of 2025, paving the way for U.S. commercialization. This milestone marks an important transition for Microbot Medical from clinical development to a commercially focused stage. The LIBERTY® system is expected to improve efficiency, reduce radiation exposure, and lessen physical strain on healthcare providers while potentially lowering overall procedure costs.
Read Announcement- Drug:
- LIBERTY® Robotic Surgical System
- Announced Date:
- December 10, 2024
- Estimated Event Date Range:
- April 1, 2025 - June 30, 2025
- Target Action Date:
- Q2 - 2025
- Indication:
- Device
Announcement
Microbot Medical announced that FDA 510(k) Clearance Anticipated During the Second Quarter of 2025
AI Summary
Microbot Medical has submitted a 510(k) premarket notification for its LIBERTY® Endovascular Robotic System and anticipates receiving FDA clearance during the second quarter of 2025. The LIBERTY® system, a single-use, fully disposable robotic device, is designed for endovascular procedures and could transform the peripheral vascular space. The clearance is a key regulatory milestone that marks the company’s transition toward commercialization in the U.S. market.
With the expected FDA clearance, Microbot Medical is preparing for a U.S. launch targeting over 2 million peripheral vascular procedures annually. The company believes that LIBERTY® will provide significant benefits, including reduced radiation exposure for medical personnel, enhanced ergonomics, and the potential to lower procedure costs. This development underscores the company’s commitment to offering innovative, accessible robotic solutions to improve patient care.
Read Announcement- Drug:
- LIBERTY® Robotic Surgical System
- Announced Date:
- September 30, 2024
- Indication:
- Device
Announcement
Microbot Medical Inc announced that it is currently experiencing an acceleration of patient enrollment for ACCESS-PVI human clinical trial for LIBERTY®.
AI Summary
Microbot Medical Inc. announced that its ACCESS-PVI human clinical trial for the LIBERTY® Endovascular Robotic Surgical System is enrolling patients faster than expected. With this accelerated enrollment, 80% of patients have already completed the follow-up period, allowing the company to anticipate an early completion of the trial. This development reinforces the company's confidence in meeting upcoming milestones and filing the FDA 510(k) submission by the end of 2024.
Both the Chairman, CEO, and President, Harel Gadot, and Chief Medical Officer, Juan Diaz-Cartelle, expressed satisfaction with the positive trend. They highlighted that the strong support and high enthusiasm at all three clinical sites have played a key role in the accelerated enrollment. This momentum is expected to help the company move efficiently toward finalizing the trial and achieving regulatory clearance.
Read Announcement- Drug:
- LIBERTY® Robotic Surgical System
- Announced Date:
- September 17, 2024
- Indication:
- Device
Announcement
Microbot Medical Inc. announced that it has successfully reached the midpoint of the ACCESS-PVI pivotal human clinical trial, enrolling and completing the follow up of 50% of the patients participating in the trial to evaluate the LIBERTY® Endovascular Robotic Surgical System.
AI Summary
Microbot Medical Inc. announced a key milestone in its ACCESS-PVI pivotal human clinical trial for the LIBERTY® Endovascular Robotic Surgical System. The company has reached the midpoint of the study by successfully enrolling and completing follow-up for 50% of the patients. This trial, which focuses on evaluating the performance and safety of the LIBERTY® system in patients undergoing Peripheral Vascular Interventions, is a major step in validating the system’s potential benefits. The company plans to complete the remaining patient enrollment and follow-up by the fourth quarter of 2024. This trial achievement is critical for supporting the future 510(k) submission to the U.S. Food and Drug Administration (FDA), as the company aims to finalize the submission process by the end of 2024. The positive progress in the trial points to promising implications for advancing endovascular robotic surgical solutions.
Read Announcement- Drug:
- LIBERTY® Robotic Surgical System
- Announced Date:
- September 17, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 - 2024
- Indication:
- Device
Announcement
Microbot Medical Inc. announced he Company expects to complete enrollment and follow up in the fourth quarter of 2024 and file its 510(k) submission with the U.S. Food and Drug Administration (FDA) by the end of 2024.
AI Summary
Microbot Medical Inc. announced significant progress on its clinical trial for the LIBERTY® Endovascular Robotic Surgical System. The pivotal ACCESS-PVI trial has reached its midpoint with 50% of patients enrolled and successfully followed up. This milestone marks an important step in the evaluation of the system for Peripheral Vascular Interventions.
Looking ahead, the company expects to complete patient enrollment and follow up in the fourth quarter of 2024. Following the trial’s completion, Microbot Medical plans to file a 510(k) submission with the U.S. Food and Drug Administration (FDA) by the end of 2024. This submission is a key step towards securing FDA clearance and will help support the future commercialization of the innovative LIBERTY® system.
Read Announcement- Drug:
- LIBERTY® Robotic Surgical System
- Announced Date:
- July 18, 2024
- Indication:
- Device
Announcement
Microbot Medical Inc. announces it has received Institutional Review Board (IRB) approval and signed a clinical trial agreement with Memorial Sloan Kettering Cancer Center, located in New York City, New York.
AI Summary
Microbot Medical Inc. has taken an important step forward by receiving Institutional Review Board (IRB) approval and signing a clinical trial agreement with Memorial Sloan Kettering Cancer Center in New York City. This collaboration marks a significant milestone in testing its LIBERTY® Endovascular Robotic Surgical System, a device aimed at improving outcomes in endovascular procedures through robotics. The clinical trial, conducted as part of an Investigational Device Exemption, will be led by Dr. Francois Cornelis, who will also serve as the principal investigator for the overall study.
By partnering with a top-tier hospital like Memorial Sloan Kettering, Microbot Medical is positioning itself to gather meaningful data that could support future market submissions to the FDA and eventual commercialization. This development underscores the potential of robotics to enhance interventional procedures and benefit both physicians and patients.
Read Announcement- Drug:
- LIBERTY® Robotic Surgical System
- Announced Date:
- July 9, 2024
- Indication:
- Device
Announcement
Microbot Medical Inc announced that Baptist Hospital of Miami, which includes Miami Cardiac & Vascular Institute and Miami Cancer Institute, has completed its first clinical procedure in a patient utilizing the LIBERTY® Endovascular Robotic Surgical System. .
AI Summary
Microbot Medical announced that Baptist Hospital of Miami—home to the Miami Cardiac & Vascular Institute and Miami Cancer Institute—recently performed its first clinical procedure using the LIBERTY® Endovascular Robotic Surgical System. Led by Dr. Ripal Gandhi, the procedure marks an important milestone in the Investigational Device Exemption trial, which is a key step toward future FDA submission and commercialization of the device.
The trial, part of the company's pivotal human clinical study, is gathering clinical data to support the system's benefits, such as reducing radiation exposure and easing physician strain during endovascular procedures. Baptist Hospital of Miami is now the second clinical site to successfully enroll a patient and execute a procedure, following Brigham & Women’s Hospital. This progress reflects Microbot Medical’s commitment to advancing robotic surgical solutions that aim to improve patient outcomes and increase accessibility in minimally invasive treatments.
Read Announcement- Drug:
- LIBERTY® Robotic Surgical System
- Announced Date:
- July 8, 2024
- Indication:
- Device
Announcement
Microbot Medical Inc. announced the completion of the first procedure in a patient utilizing its LIBERTY® Endovascular Robotic Surgical System.
AI Summary
Microbot Medical Inc. announced a significant milestone with the successful completion of the first-ever procedure using its LIBERTY® Endovascular Robotic Surgical System. The procedure was performed on a patient at Brigham and Women’s Hospital in Boston, Massachusetts, as part of the company’s pivotal human clinical trial. Led by Dr. Dmitry Rabkin, the trial aims to gather important clinical data that will eventually support the company’s future submission to the FDA. This system is designed to enhance endovascular procedures by reducing the need for bulky equipment, lowering radiation exposure, and easing the strain on physicians during operations. The completion of this initial clinical case marks a promising step toward broader commercialization and enhanced accessibility for U.S. physicians, paving the way for more patients to benefit from advanced micro-robotic surgical technology.
Read Announcement- Drug:
- LIBERTY® Robotic Surgical System
- Announced Date:
- June 20, 2024
- Indication:
- Device
Announcement
Microbot Medical Inc. announced its agreement with Brigham and Women's Hospital (BWH), a leading academic medical center located in Boston, Massachusetts, to serve as one of the sites to perform the pivotal human clinical trial for its LIBERTY® Endovascular Robotic Surgical System, as part of its Investigational Device Exemption ("IDE") application.
AI Summary
Microbot Medical Inc. announced a new agreement with Brigham and Women’s Hospital (BWH) in Boston, Massachusetts, to serve as one of the sites for its pivotal human clinical trial. This trial will evaluate the LIBERTY® Endovascular Robotic Surgical System as part of the company’s Investigational Device Exemption (IDE) application. The innovative system is designed to enhance endovascular procedures by reducing the need for bulky equipment, lowering radiation exposure, and lessening physician strain during operations.
BWH has already completed its Site Initiation Visit, where clinical staff received training on the study protocols and the robotic system. Under the leadership of Dr. Dmitry Rabkin, the hospital will play a key role in the clinical research efforts, marking an important step in advancing this new technology and improving patient outcomes. This collaboration is a significant milestone for Microbot Medical as it works to expand the trial to additional leading centers.
Read Announcement- Drug:
- LIBERTY® Robotic Surgical System
- Announced Date:
- April 29, 2024
- Indication:
- Device
Announcement
Microbot Medical Inc. today reports that the first phase of the previously announced collaboration with Corewell Health has been completed, which demonstrated the LIBERTY® System's technical capabilities and outlines potential future applications in a range of endovascular interventions.
AI Summary
Microbot Medical Inc. has announced that the first phase of its collaboration with Corewell Health is now complete. In this phase, the LIBERTY® Endovascular Robotic Surgical System’s technical abilities were demonstrated through successful coronary guidewire navigation and stent delivery in pre-clinical studies. The results show that the LIBERTY System can perform complex tasks and point to broader potential applications in a range of endovascular interventions. This achievement supports the plan to develop telerobotic procedures, where remote centers can safely and effectively perform interventions using the system. The collaboration, which is set to continue through multiple phases, is exploring innovative remote capabilities that could simplify minimally invasive surgeries and improve patient outcomes. With these promising early results, both Microbot Medical and Corewell Health are eager to further investigate and expand the system’s applications in the field of endovascular treatment.
Read Announcement
