FDA OKs Asensus’ Senhance Robot for Urology Procedures

Asensus Surgical has gained U.S. Food and Drug Administration 510(k) clearance to expand the indication of its Senhance surgical robotic system to treat adult and pediatric urology patients.

Senhance has been successfully used for urology procedures outside the U.S. for several years. The expanded indication opens the door to leverage Senhance’s advantages in the over 185,000 urological surgical procedures annually in the U.S.

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 said the FDA nod is an exciting step in the evolution of urological surgery for adult and pediatric patients.

“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,” Dr. Koh told the press.

“This FDA clearance marks another milestone for Asensus Surgical and represents an additional indication expansion in the U.S. market,” said Anthony Fernando, Asensus 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.”

Last month, Asensus Surgical entered a merger agreement with KARL STORZ Endoscopy-America, which is expected to close in Q3 of this year.