Microbot Medical (Nasdaq:MBOT) announced today that it filed an FDA investigational device exemption (IDE) application for its surgical robot.
Braintree, Massachusetts-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 believes 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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