Asensus Surgical Senhance surgical robot ISU
The Intelligent Surgical Unit powers the Senhance surgical robot system. [Image courtesy of Asensus Surgical]

Asensus Surgical announced today that FDA has cleared an expanded pediatric indication for its Senhance robotic surgery system.

Research Triangle Park, North Carolina–based Asensus says Senhance is the first and only digital laparoscopic surgery solution for pediatric patients. During the company’s fourth-quarter earnings announcement early this month, it said it expected the pediatric indication this year.

The Senhance system’s Intelligent Surgical Unit combines 3 mm instrumentation, a 5 mm camera scope, haptic feedback, and advanced clinical intelligence, according to Asensus.

Asensus’ Senhance system also has regulatory approval for pediatric patients in the EU and Japan. The company reports strong early clinical utilization in Europe. Surgeons in Europe have performed pediatric general, upper GI, colorectal, and urologic procedures using Senhance.

“We are excited to bring the benefits of surgical robotic technology to the underserved pediatric patient population in the United States. The Senhance System is uniquely qualified to meet the needs of pediatric surgeons,” Asensus Surgical CEO Anthony Fernando said in a news release.

Dr. Thom Lobe, a pediatric surgeon at at the Sinai Health System in Chicago, added: “The Senhance System is the perfect robotic platform for use in pediatric patients. No other robotic system uses reusable 3mm instruments suitable for smaller patients.”

More about Asensus Surgical

The U.S. pediatric indication for the Senhance system is but the latest in a string of recent news out of Asensus. The company is among a host of companies —  big and small — that are seeking to compete against Intuitive in the soft-tissue robotics space. (Here are 16 you need to knowand here are another eight.)

Other 2023 announcements out of Asensus included multiple partnerships and the unveiling of the next-generation Luna surgical robot.

Senhance is presently available for sale in the U.S., EU, Japan, Russia and other select countries.