Microbot Medical recently announced that it has submitted a 510(k) premarket notification to the US Food and Drug Administration (FDA) for its Liberty endovascular robotic system.
A press release details that Liberty is the world’s first single-use, fully disposable robotic system for endovascular procedures. The 510(k) submission follows the successful completion of Microbot Medical’s multicentre, 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 US commercialisation activities expected to commence after the clearance.
“This is a pivotal milestone for our company, as the 510(k) submission reflects the commencement of our transition to a commercially focused company,” commented Harel Gadot, chairman, chief executive officer and president. “We are excited to transition our focus towards preparing for our expected US launch in the second quarter of 2025 and targeting the more than two million peripheral vascular procedures performed in the USA 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.”
Microbot Medical states in the press release that Liberty eliminates the need for large and expensive capital equipment and streamlines customers’ access to robotics. With its remote control, Liberty is designed to 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.
