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][4] - The Senhance System is designed to enhance surgical precision and control through advanced digital capabilities, making it suitable for urological procedures [1][2]. 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, which has been approved for use globally [3]. Market Context - In the U.S., healthcare providers perform over 185,000 urological surgical procedures annually, indicating a substantial market opportunity for the Senhance System [1]. - The expanded indication for the Senhance System is expected to leverage its advantages in the U.S. patient population, where it has already been successfully utilized for urology procedures outside the U.S. [1].