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Home » Microbot Medical submits Liberty surgical robot to FDA

Microbot Medical submits Liberty surgical robot to FDA

December 10, 2024 By Sean Whooley

This is a Microbot Medical marketing image of its Liberty surgical robotic system.
Liberty surgical robotic system [Image courtesy of Microbot Medical]
Microbot Medical (Nasdaq:MBOT) announced today that it submitted an FDA 510(k) premarket notification for its Liberty surgical robot.

Microbot designed its Liberty single-use endovascular surgical robot for potential use in neurovascular, cardiovascular and peripheral vascular procedures. The system includes a compact design and remote operating capabilities to reduce radiation exposure and physical strain on physicians.

Braintree, Massachusetts-based Microbot believes Liberty’s remote operation could potentially make it the first system to democratize endovascular interventional procedures. The company says it’s the world’s first single-use, fully disposable robotic system for those procedures.

Microbot’s FDA submission follows the completion of a study of Liberty in humans undergoing peripheral vascular interventions this year. The company expects to receive clearance during the second quarter of 2025. It plans to begin U.S. commercialization activities following the regulatory nod.

In October, the company laid out marketing plans for Liberty. It expects to begin building out commercial infrastructure, which includes hiring a seasoned healthcare executive to lead sales efforts.

“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, chair, 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.

“Based on feedback from physicians and the medical community, we believe that Liberty is positioned to redefine the peripheral endovascular space by introducing the world’s first commercially available single-use robotic system.”

Filed Under: 510(k), Cardiovascular, Food & Drug Administration (FDA), Health Technology, Neurological, Regulatory/Compliance, Robotic-Assisted, Surgical, Surgical Robotics, Vascular Tagged With: FDA, Microbot Medical

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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