Summary: Microbot Medical has submitted a 510(k) notification for Liberty, its single-use robotic system for endovascular procedures. Following a successful clinical trial, the company anticipates FDA clearance in Q2 2025. Liberty’s innovative design aims to improve efficiency, reduce radiation exposure, and lower costs, redefining the peripheral endovascular space.

Key Takeaways:

  • Innovative Technology: Liberty is positioned as the first commercially available single-use robotic system, designed to enhance procedural efficiency and reduce costs.
  • Market Transition: Microbot Medical is shifting focus to commercialization, targeting over 2 million annual peripheral vascular procedures in the U.S. after anticipated FDA clearance in 2025.

Microbot Medical Inc., developer of the innovative single-use Liberty Endovascular Robotic System, has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for Liberty.

Evaluating Liberty in Peripheral Vascular Interventions

Liberty is a single-use, fully disposable robotic system for endovascular procedures. The 510(k) submission follows the successful completion of its multi-center, single-arm trial to evaluate the performance and safety of Liberty in human subjects undergoing Peripheral Vascular Interventions.

The company anticipates FDA marketing clearance during the second quarter of 2025, with U.S. commercialization activities expected to commence after the clearance.

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Transition to Commercial Focus

“This is a pivotal milestone for our Company, as the 510(k) submission reflects the commencement of our transition to a commercially focused company,” said Harel Gadot, chairman, CEO and president. “We are excited to transition our focus towards preparing for our expected U.S. launch in the second quarter of 2025 and targeting the more than 2 million peripheral vascular procedures performed in the U.S. each year. We believe, based on feedback from physicians and the medical community, that Liberty is positioned to redefine the peripheral endovascular space with the introduction of the world’s first commercially available single-use robotic system.”

Innovative Design and Benefits of Liberty

Liberty is designed to eliminate the need for large and expensive capital equipment and streamlines customers’ access to robotics. With its remote control, Liberty can significantly reduce radiation exposure to physicians and staff, and improve ergonomics, which has the potential to reduce the physical strain on healthcare providers.

The company also believes that Liberty has the potential to lower procedure costs, increase procedure efficiency, and improve the overall quality of care.