Asensus Surgical, Inc. announced that it has received 510(k) clearance from the FDA for an expanded indication to treat pediatric patients with the Senhance® System. The Senhance System is already approved for pediatric patients in the EU and Japan. With the combination of 3mm instrumentation, 5mm camera scope, haptic feedback, and advanced clinical intelligence provided by the Intelligent Surgical Unit™, the Company believes that the Senhance System is uniquely positioned to bring the benefits of surgical robotics to pediatric patients in a way that no other platform on the market can, by offering a unique and unmatched reduction in invasiveness on a robotic platform.

The company has seen strong early clinical utilization in Europe, with surgeons having successfully performed pediatric general, upper GI, colorectal and urologic procedures using the Senhance System. The Senhance System is now indicated to perform pediatric procedures in the U.S., Europe, and Japan.