FDA grants 510(k) clearance to Senhance Surgical System in urology

The FDA has granted 510(k) clearance to an expanded indication of the Senhance Surgical System for use in adult and pediatric patients undergoing urologic procedures, announced Asensus Surgical, the developer of the device, in a news release.¹ 

The Senhance Surgical System was first approved in the US in October 2017.

According to Asensus, the Senhance Surgical System is a digital laparoscopy system “intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction.”²

The device utilizes augmented intelligence and deep learning technologies to increase surgeon control and reduce variability, making it the first intraoperative augmented intelligence technology approved for robotic surgery, the company also noted.

“This FDA clearance marks another milestone for Asensus Surgical and represents an additional indication expansion in the US market,” said Anthony Fernando, president and CEO of Asensus Surgical, in the news release.¹ “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.”

According to the news release from Asensus, the Senhance Surgical System has been utilized in urologic procedures outside of the US for several years. With this 510(k) clearance, urologists within the US now have access to the device for assistance in urologic robotic surgery as well.

The Senhance Surgical System was first approved in the US in October 2017 for laparoscopic surgery.³ Since then, the device has been granted several expanded indications, including for use in pediatric patients, for general surgery, and now, for urologic procedures.

The device is also approved in the EU and Japan, which both include approved indications for use in pediatric patients. For pediatric patients in the US, the device is indicated for patients aged 2 and older who weigh 10 kg or more.²

“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,” concluded Chester J. Koh, MD, MBA, FACS, FAAP, in the news release.¹ Koh is a pediatric urologist, the director of the Pediatric Robotic Surgery Program, and a professor of urology and pediatric urology at Baylor College of Medicine in Houston, Texas.

References

1. Asensus Surgical receives FDA 510(k) clearance for Senhance Surgical System in urology. News release. Asensus Surgical, Inc. Published online and accessed July 23, 2024. https://ir.asensus.com/news-releases/news-release-details/asensus-surgical-receives-fda-510k-clearance-senhance-surgical

2. Indications for use. Asensus Surgical. Accessed July 23, 2024. https://www.asensus.com/indications-for-use

3. TransEnterix announces US 510(k) FDA clearance for Senhance Surgical Robotic System. News release. October 13, 2017. Accessed July 23, 2024. https://ir.asensus.com/news-releases/news-release-details/transenterix-announces-us-510k-fda-clearance-senhance-surgical