Asensus Surgical, Inc. (NYSE American: ASXC), a global leader of innovative digital solutions for the operating room, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for an expanded indication to treat adult and pediatric Urology patients with the Senhance® Surgical System.
“This FDA clearance marks another milestone for Asensus Surgical and represents an additional indication expansion in the U.S. market,” said Anthony Fernando, Asensus Surgical President and CEO. “The Senhance System’s precision and advanced digital capabilities make it uniquely suited for urological procedures, offering surgeons the benefit of digital tools and smaller instrumentation. We are excited to bring this technology to urologists and their patients across the United States.”
Healthcare providers perform upwards of 185,000 urological surgical procedures each year in the United States.* While the Senhance System has been successfully utilized for Urology procedures outside the U.S. for several years, this expanded indication will open the door to this important specialty to leverage the advantages of the Senhance System in the U.S. patient population.
Chester Koh MD, MBA, FACS, FAAP, a pediatric urologist and director of the Pediatric Robotic Surgery Program and Professor at Baylor College of Medicine in Houston, Texas noted that, “With a full suite of 3mm and 5mm instruments and digital integrations, the Senhance Surgical System combines the benefits of robotics and minimally invasive surgery. This is an exciting step in the evolution of Urological surgery for both adult and pediatric patients.”
The Senhance Surgical System is designed to increase surgeon control and reduce variability through Augmented Intelligence and deep learning capabilities.
