FDA clears new surgical robot

Editor's Note

The Food and Drug Administration (FDA) on October 13 cleared the Senhance System (TransEnterix Surgical Inc, Morrisville, North Carolina), a new robotically-assisted surgical device.

The design of the Senhance System allows surgeons to sit at a console unit that provides a 3-D high-definition view of the surgical field and control three robotic arms remotely. The system also includes technological characteristics such as force feedback and eye-tracking.

The FDA, which reviewed the Senhance System through the premarket clearance 510(k) pathway, concluded that study data, real-world evidence, and performance testing demonstrated the substantial equivalence of the Senhance System to the da Vinci Si IS3000 for gynecological and colorectal procedures.

Today, the U.S. Food and Drug Administration cleared the Senhance System, a new robotically-assisted surgical device (RASD) that can help facilitate minimally invasive surgery. "Minimally invasive surgery helps reduce pain, scarring and recovery time after surgery," said Binita Ashar, M.D., director of the Division of Surgical Devices in the FDA's Center for Devices and Radiological Health.

Read More >>