ZEUS robotic surgical system

Microbot Medical Successfully Completed Integral Part of the Verification and Validation Process

Retrieved on: 
Monday, November 13, 2023
Clinical trial, V&V, ZEUS robotic surgical system, Electromagnetic compatibility, IDE, Verification, EMC, FDA

BRAINTREE, Mass., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Robotic Surgical System, today announces it had successfully completed the Electromagnetic Compatibility (EMC) testing section of the Verification and Validation (V&V) process.

Key Points: 
  • BRAINTREE, Mass., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Robotic Surgical System, today announces it had successfully completed the Electromagnetic Compatibility (EMC) testing section of the Verification and Validation (V&V) process.
  • V&V are distinct procedures employed to ensure that a product, service, or system, aligns with specified requirements and effectively serves its intended purpose.
  • The V&V, together with the pre-clinical pivotal study Microbot recently completed, are essential elements to an Investigational Device Exemption (IDE) submission for the FDA to commence clinical trials as part of the pathway for and receiving the required regulatory clearance.
  • “The success in completing the EMC testing of our V&V testing, we believe, affirms our dedication to ensuring the highest quality and safety standards for our LIBERTY Robotic Surgical System.

Microbot Medical Granted Registered Trademark from The U.S. Patent and Trademark Office

Retrieved on: 
Wednesday, November 8, 2023
Patent, ZEUS robotic surgical system, United States patent law, 3D printing, Fine chemical

BRAINTREE, Mass., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), the developer of the LIBERTY® Robotic Surgical System, the first single-use endovascular robotic system, today announced it had been granted a registered trademark from the US Patent and Trademark Office.

Key Points: 
  • BRAINTREE, Mass., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), the developer of the LIBERTY® Robotic Surgical System, the first single-use endovascular robotic system, today announced it had been granted a registered trademark from the US Patent and Trademark Office.
  • The trademark “One & Done®” was given to the feature of the LIBERTY Robotic Surgical System which is being developed to integrate guidewires, microcatheters and other instruments required for complete endovascular procedures using the device.
  • With this trademark, the Company continues to expand its proprietary assets, including numerous approved and pending patents all over the world, and differentiate its product’s capabilities.

Microbot Medical Reveals Successful Short Term Follow Up Outcomes from its Pivotal Pre-Clinical Study

Retrieved on: 
Tuesday, October 31, 2023
FDA, ZEUS robotic surgical system, Investigational device exemption, V&V, Human, IDE, Clinical trial, Animal, Safety, Investigator's brochure, Nursing

The pivotal study was conducted by three leading interventional radiologists that utilized the LIBERTY Robotic Surgical System to reach a total of 48 animal targets.

Key Points: 
  • The pivotal study was conducted by three leading interventional radiologists that utilized the LIBERTY Robotic Surgical System to reach a total of 48 animal targets.
  • This new data follows the recently announced successful initial outcomes from the pivotal pre-clinical study.
  • A total of 6 LIBERTY Systems were used in the study, each was used to reach a total of 8 targets.
  • "We are excited to share additional positive outcomes of our pivotal pre-clinical study.

Microbot Medical Received Confirmation for the Commencement of Its CE Mark Approval Process During the First Half of 2024

Retrieved on: 
Tuesday, October 24, 2023
Quality management system, FDA, ZEUS robotic surgical system, MDR, Certification, QMS, European, CE marking, ISO, Medical device

BRAINTREE, Mass., Oct. 24, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Robotic Surgical System, today announces it has received confirmation for the commencement of the process to support its future CE Mark approval, and to ultimately allow the Company to market the LIBERTY® Robotic Surgical System in Europe as well as other regions who accept the CE Mark.

Key Points: 
  • According to the confirmation, the Company will commence audits for ISO 13485 certification to ensure its compliance with the Quality Management System (QMS) requirements of the EU Medical Devices Regulation (MDR 2017/745), during the first half of 2024.
  • The Company had previously taken the first step to advance its European program by engaging with a leading Notified Body, who recently confirmed dates for conducting the required audits.
  • The audits for Microbot’s ISO 13485 certification will incorporate an off-site audit that includes a review of the Company’s quality system and the LIBERTY® Robotic Surgical System Technical File, followed by an on-site audit at the Company’s facilities.
  • “We intend that this process will be conducted in parallel with our FDA approval efforts, to allow us to capture as many markets across the globe as we prepare for future commercialization.”

Microbot Medical Announces Grant of Summary Judgment in its Favor and Dismissal of Counterclaim Against Company

Retrieved on: 
Thursday, October 19, 2023
Magistrate, ZEUS robotic surgical system, Prejudice, Court, Judgement, Recommendation, District court, Defendant, Motion

In its Memorandum Decision and Order, the Court adopted in full the Magistrate Judge’s Report and Recommendation, which had recommended that the Court grant Microbot’s motion for summary judgment and dismiss defendant’s counterclaim with prejudice.

Key Points: 
  • In its Memorandum Decision and Order, the Court adopted in full the Magistrate Judge’s Report and Recommendation, which had recommended that the Court grant Microbot’s motion for summary judgment and dismiss defendant’s counterclaim with prejudice.
  • In its ruling, in part, the Court held that the defendant failed to raise a triable issue of fact in support of his claim.
  • Microbot previously announced that a judgment in the action against defendant and in favor of Microbot in the amount of $484,614.30 was entered, and no appeal was filed.
  • As the counterclaim has now been dismissed, the Company is now seeking to enforce the judgment as against defendant.

Microbot Medical Announces Successful Initial Outcomes from Its Pivotal Pre-Clinical Study with the LIBERTY® Robotic Surgical System

Retrieved on: 
Tuesday, October 17, 2023
ZEUS robotic surgical system, V&V, FDA, Investigational device exemption, IDE, Clinical trial, Human

This pivotal study, together with the verification and validation studies, is expected to serve as the basis for the IDE submission to the FDA

Key Points: 
  • This pivotal study, together with the verification and validation studies, is expected to serve as the basis for the IDE submission to the FDA
    BRAINTREE, Mass., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Robotic Surgical System, today announces the successful initial outcomes of using the LIBERTY Robotic Surgical System in its pivotal pre-clinical study.
  • The pivotal study was conducted by three leading interventional radiologists that utilized the LIBERTY Robotic Surgical System to reach a total of 48 animal targets.
  • A total of 6 LIBERTY Systems were used in the study, each was used to reach a total of 8 targets.
  • The system operated without any issues in all cases, achieving our initial objectives for the study," said Simon Sharon, CTO & GM.

Microbot Medical Engages CRO to Support its Upcoming U.S. Pivotal Clinical Trial

Retrieved on: 
Wednesday, September 27, 2023
Partnership, ZEUS robotic surgical system, Clinical trial, Contract research organization, Research, Food and Drug Administration Amendments Act of 2007, FDA, Food, Safety, Fine chemical, Pharmaceutical industry

This is an additional step in the preparations to the commencement of the Company's planned upcoming clinical trial.

Key Points: 
  • This is an additional step in the preparations to the commencement of the Company's planned upcoming clinical trial.
  • The CRO will provide an array of comprehensive research management services, leveraging their expertise and resources to bolster Microbot's clinical trial initiatives.
  • The CRO will also furnish guidance throughout the clinical trial process, along with essential functional support and resources, to ensure a seamless execution of the Company's U.S. pivotal clinical trial.
  • The Company's upcoming U.S. pivotal clinical trial has been designed to evaluate the safety and efficacy of the LIBERTY® Robotic Surgical System in endovascular procedures.

MMI’s Symani® Robotic Surgical System Surpasses 500 Clinical Procedures

Retrieved on: 
Monday, September 25, 2023
Health, Surgery, Health Technology, Other Health, General Health, Biotechnology, HUS, Surgeon, Tremor, Freedom, University Hospitals Cleveland Medical Center, Quality of life, Head, ZEUS robotic surgical system, Hospital, Lymphedema, MD, Patient, European, Microsurgery, Filtration, Robotics, Trauma, MMI, 500th, Dentistry, Nursing, Doctor of Philosophy

The Symani Surgical System is a first-of-its kind robotic technology that uniquely addresses the scale and complexities of microsurgery and supermicrosurgery.

Key Points: 
  • The Symani Surgical System is a first-of-its kind robotic technology that uniquely addresses the scale and complexities of microsurgery and supermicrosurgery.
  • It is a robotic platform that enables expanded options for patients in need of soft tissue open surgical procedures, such as free flap reconstructions, lymphatic surgery, trauma reconstructions, and peripheral nerve repairs.
  • Since the first in-human cases in October 2020, the system has been used in over 500 procedures, rapidly increasing patient access to surgical treatment options as surgeons become comfortable using the technology.
  • Of the 500 procedures completed to date, approximately 75 percent have been free flap surgeries, and 16 percent have been lymphatic repairs.

Microbot Medical Gains Global Recognition; Professor Vincent Vidal to Present an Abstract on The LIBERTY® Robotic Surgical System at CIRSE 2023

Retrieved on: 
Friday, September 8, 2023
Cardiovascular and Interventional Radiological Society of Europe, Miniature, ZEUS robotic surgical system, Clinical trial, Coronavirus Scientific Advisory Board, CIRSE, Doctor of Philosophy, Aix-Marseille University, MDR, Professor, Circulatory system, FIH, FDA, Microbotics

BRAINTREE, Mass., Sept. 08, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) is honored to announce the continuous growing global recognition of its LIBERTY® Robotic Surgical System, to be presented in an abstract at the Annual Congress of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) on September 9, 2023.

Key Points: 
  • BRAINTREE, Mass., Sept. 08, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) is honored to announce the continuous growing global recognition of its LIBERTY® Robotic Surgical System, to be presented in an abstract at the Annual Congress of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) on September 9, 2023.
  • The abstract is to be presented by Professor of Interventional Radiology Vincent Vidal, M.D.
  • PhD, from the Aix-Marseille University and a Scientific Advisory Board Member of Microbot.
  • The team expressed their positive experiences and satisfaction from using the Company’s Robotic Surgery System.

Microbot Medical Boosts Manufacturing and Commercialization Capabilities for its Robotic Surgical System

Retrieved on: 
Tuesday, August 15, 2023
Clinical trial, NPI, Research, ZEUS robotic surgical system, 3D printing, Medical device

BRAINTREE, Mass., Aug. 15, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), the developer of the LIBERTY® Robotic Surgical System, the first single-use endovascular robotic system, announces another step in its commitment to advance the commercialization processes of LIBERTY® with the signing of a manufacturing agreement with B.Y.

Key Points: 
  • BRAINTREE, Mass., Aug. 15, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), the developer of the LIBERTY® Robotic Surgical System, the first single-use endovascular robotic system, announces another step in its commitment to advance the commercialization processes of LIBERTY® with the signing of a manufacturing agreement with B.Y.
  • The agreement governs the manufacturing of the Company's LIBERTY® Robotic Surgical System, for its first in human clinical trial as well as for the initial LIBERTY systems that are expected to be marketed following the completion of regulatory requirements.
  • Medimor provides new product introduction (NPI) solutions and full turnkey manufacturing for medical devices as a one stop shop contract manufacturing service, including integration, parts cleaning, clean room assembly and testing.
  • “We believe that the manufacturing agreement supports our efforts to deliver a state-of-the-art advanced robotic system and facilitates our next steps."