Microbot Medical Inc. announced on December 10, 2024, that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA). This submission seeks commercial approval for the company's innovative single-use LIBERTY Endovascular Robotic System.
The FDA 510(k) submission follows the successful completion of the pivotal human clinical trial for LIBERTY. Microbot Medical anticipates receiving FDA 510(k) clearance during the second quarter of 2025, which would enable the commencement of commercialization activities.
The LIBERTY system is designed as the world's first single-use, fully disposable endovascular robotic system, aiming to eliminate the need for large capital equipment. Its remote control is intended to significantly reduce radiation exposure for physicians and staff, improve ergonomics, and potentially lower procedure costs.
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