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Asensus Surgical Receives FDA 510(k) Clearance for Senhance Surgical System

Tuesday, March 21, 2023

Asensus Surgical announced that it has received 510(k) clearance from the FDA for an expanded indication to treat paediatric patients with the Senhance® System. The Senhance System is already approved for paediatric 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 Senhance System is uniquely positioned to bring the benefits of surgical robotics to paediatric 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. Its early clinical utilisation is noticed in Europe, where surgeons have successfully performed paediatric general, upper gastrointestinal, colourectal and urological procedures using the Senhance System.

Senhance offers the first and only digital laparoscopic surgery solution for paediatric patients. No other robotic system uses reusable 3mm instruments suitable for smaller patients. For those familiar with laparoscopic surgery, the system is easy to learn and has several advantages including economical value, a camera system controlled by the surgeon’s eyes, and improved safety features such as haptic feedback.