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Whereas over 5 million endovascular procedures are carried out within the U.S. annually, Microbot says lower than 1% are completed robotically. | Supply: Microbot Medical
Microbot Medical Inc. this week mentioned it has submitted a 510(okay) premarket notification to the U.S. Meals and Drug Administration for LIBERTY, a single-use, totally disposable robotic system for endovascular procedures. The corporate mentioned it expects the FDA to clear LIBERTY in the course of the second quarter of 2025.
“This can be a pivotal milestone for our firm, because the 510(okay) submission displays the graduation of our transition to a commercially centered firm,” said Harel Gadot, the chairman, CEO, and president of Microbot Medical.
“We’re excited to transition our focus in direction of getting ready for our anticipated U.S. launch within the second quarter of 2025 and concentrating on the greater than 2 million peripheral vascular procedures carried out within the U.S. annually,” he mentioned. “We consider, based mostly on suggestions from physicians and the medical neighborhood, that Liberty is positioned to redefine the peripheral endovascular area with the introduction of the world’s first commercially out there single-use robotic system.”
Microbot Medical is a pre-commercial-stage medical expertise supplier. It mentioned its imaginative and prescient is to enhance the standard of look after tens of millions of sufferers and suppliers globally. The Braintree, Mass.-based firm mentioned LIBERTY is step one towards its aim of rethinking how robotics can profit healthcare.
Extra in regards to the LIBERTY system
LIBERTY eliminates the necessity for giant and costly capital tools and streamlines clients’ entry to robotics, based on Microbot Medical. The corporate mentioned it designed the system with a distant management to considerably scale back radiation publicity to physicians and employees, and enhance ergonomics. This might scale back the bodily pressure on healthcare suppliers.
The surgical robotic can be utilized in neurovascular, cardiovascular, and peripheral vascular procedures. The system features a compact design and distant working capabilities. Microbot additionally claimed that LIBERTY has the potential to decrease process prices, improve process effectivity, and enhance the general high quality of care.
The 510(okay) submission follows Microbot’s multi-center, single-arm trial to guage the efficiency and security of LIBERTY in human topics present process peripheral vascular interventions.
In July, the corporate accomplished the primary process in a scientific trial utilizing its surgical robotic. Investigators within the firm’s pivotal human scientific trial accomplished the process at Brigham and Girls’s Hospital (BWH) in Boston.
Latest highlights for the corporate embody expanded U.S. operations forward of the IDE submission to arrange for the following steps. Microbot already had momentum after constructive outcomes from its good laboratory practices (GLP) pre-clinical examine.
The corporate additionally secured a $2.154 million settlement of a lawsuit involving a securities buy settlement in January.
