Microbot Medical, a medical device company based in Braintree, MA, has filed an Investigational Device Exemption (IDE) application with the FDA seeking approval to begin human clinical trials for its Liberty robotic surgery system. The innovative robot is designed for minimally invasive procedures in the neurovascular, cardiovascular, and peripheral vascular space.
The compact Liberty platform features a remote operating capability that allows physicians to conduct procedures from an adjacent room. This aims to reduce radiation exposure and physical strain during lengthy and complex endovascular surgeries.
“This is an important milestone for the company, and another step towards achieving FDA clearance for the Liberty system,” stated Microbot CEO Harel Gadot.
The IDE application sets the stage for pivotal human trials, providing a pathway to potential commercialization. It follows a successful pre-clinical Good Laboratory Practice (GLP) study highlighting safety and effectiveness.
The news comes on the heels of Microbot expanding US operations in anticipation of this regulatory filing. It also follows a $2.15 million legal settlement last December.
Surgical robotics has exploded in recent years, led by Intuitive Surgical’s wildly successful da Vinci system. Intuitive itself just filed for FDA 510(k) clearance for its next-gen da Vinci 5.
Other recent events include Virtual Incision’s miniaturized MIRA robot launching to the International Space Station for zero gravity medical testing. Lincoln, NE-based Virtual Incision will have surgeons on Earth remotely manipulate the device.
With momentum building, Microbot joins an increasingly crowded field all vying for a piece of the fast-growing medical robotics market. But Liberty’s vascular focus combined with its remote operation capabilities give it a unique value proposition.
FDA approval would position the company for commercial success and provide surgeons an innovative tool for performing complex minimally invasive procedures. Gadot and his team now anxiously await the regulatory decision that could launch Microbot into the surgical big leagues alongside medtech titans like Intuitive.
