Asensus Surgical Gets Pediatric Indication for Robotic Laparoscopic Device

Asensus Surgical has received an expanded FDA 510(k) clearance for pediatric use of its Senhance surgical system, the first robotic laparoscopic surgery solution for this age group.

Given the small size of patients, pediatric surgery seeks to use “the least invasive instruments and scopes, while maintaining a high level of precision and stability,” the company said, adding that no other robotic system uses reusable 3mm instruments for these smaller patients.

Senhance features a camera controlled by the surgeon’s eyes, with safety features such as haptic feedback — the use of touch to communicate with the user, like the vibration of a mobile phone.

The system is cleared for use in general and gynecological laparoscopic surgeries for patients aged two and older, weighing 10 kg or more.

Senhance previously earned a CE mark for use in markets that accept the European certification.