Microbot Medical submits 510(k) to FDA for Liberty endovascular robotic system
With remote control functionality, Liberty is designed to reduce radiation exposure for physicians and staff and improve ergonomics during procedures.
Credit: Microbot Medical, Inc.
Microbot Medical Inc. announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration for the Liberty Endovascular Robotic System. According to the company, Liberty is the world’s first single-use, fully disposable robotic system designed to assist clinicians with endovascular procedures.
The submission follows the successful completion of a multi-center, single-arm trial evaluating the performance and safety of Liberty in patients undergoing peripheral vascular interventions. The company anticipates FDA clearance in the second quarter of 2025 and plans to begin commercialization activities shortly afterward.
“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 of Microbot Medical, in a news release. “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.”
The Liberty system does not require large or costly capital equipment, making it potentially more accessible to health care facilities, according to the company. With remote control functionality, it is also designed to reduce radiation exposure for physicians and staff and improve ergonomics during procedures. The company believes Liberty’s single-use format can lower procedure costs and increase efficiency while improving overall care.
"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,” Gadot said.
Microbot Medical, based in Braintree, Mass., is a pre-commercial stage medical technology company focusing on robotics for endovascular interventions.
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