Microbot Medical submits Liberty surgical robot for FDA IDE
Microbot Medical filed an FDA investigational device exemption (IDE) application for its surgical robot. Braintree, Mass.-based Microbot designed the Liberty 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.
Microbot said Liberty’s remote operation could potentially make it the first system to democratize endovascular interventional procedures.
Approval of the IDE application would enable a pivotal human clinical trial for Liberty in the U.S.
The company recently expanded its U.S. operations ahead of the now-filed IDE submission to prepare for its next steps. It also has momentum from its positive good laboratory practices (GLP) pre-clinical study. Other recent news around Microbot includes a $2.154 million settlement of a lawsuit involving a securities purchase agreement.
“This is an important milestone for the company, and it is another step forward in our journey to achieve FDA clearance for the Liberty endovascular robotic surgical system,” said Harel Gadot, CEO, president and chair of Microbot Medical.
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Surgical robotics remains a hot space in medtech. Intuitive Surgical recently submitted for FDA 510(k) clearance of its next-generation da Vinci 5 multiport surgical robot. The da Vinci 5 will join Intuitive’s existing da Vinci robotic surgical system portfolio alongside the multiport X and Xi systems and the single-port SP. There is also Ion, Intuitive’s robotic-assisted platform for minimally invasive biopsy in the lung.
Virtual Incision’s MIRA surgical robot system recently arrived at the International Space Station (ISS). Lincoln, Nebraska–based Virtual Incision said its spaceMIRA device sat aboard a Northrop Grumman Cygnus cargo spacecraft carried by a SpaceX Falcon 9 rocket. The robot will assess the impact of zero gravity when performing simulated surgical tasks. During a portion of the experiment, the company plans for a surgeon operator at its Nebraska headquarters to remotely control the robot.
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Microbot Medical’s LIBERTY system is a single-use endovascular robotic surgical system. | Source: Microbot Medical
Editor’s Note: This article first appeared on sister website MassDevice.
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