Asensus Surgical Receives FDA 510(k) Clearance for Senhance Surgical System in Urology

Core Insights - Asensus Surgical, Inc. has received FDA 510(k) clearance for the Senhance® Surgical System to treat adult and pediatric Urology patients, marking a significant milestone for the company in expanding its market presence in the U.S. [1] - The Senhance System is designed to enhance surgical precision and reduce variability through Augmented Intelligence and deep learning capabilities, making it suitable for urological procedures [2][3] - The U.S. healthcare providers conduct over 185,000 urological surgical procedures annually, indicating a substantial market opportunity for the Senhance System [1] Company Overview - Asensus Surgical is recognized as a leader in innovative digital solutions for the operating room, focusing on making surgery more accessible and predictable while achieving superior outcomes [3] - The company is committed to revolutionizing surgery with its intra-operative Augmented Intelligence technology and has a global presence with system placements [3] Market Context - The expanded indication for the Senhance System will allow healthcare providers in the U.S. to leverage its advantages in urological surgery, which has been successfully utilized in other markets for several years [1] - The integration of a full suite of 3mm and 5mm instruments with digital capabilities positions the Senhance System as a significant advancement in minimally invasive surgery for both adult and pediatric patients [2]