TransEnterix Receives FDA Clearance for First Machine Vision System in Robotic Surgery
The Intelligent Surgical Unit Enables Augmented Intelligence on the Senhance Surgical System
“We are pleased to have received this important clearance earlier than expected. Machine vision is the next major advance in digital surgery,” said
The ISU enables machine vision driven control of the camera for a surgeon by responding to commands and recognizing certain objects and locations in the surgical field. The ISU hardware is also designed to be compatible with planned future augmented intelligence features such as scene cognition and surgical image analytics that are expected to continue to drive meaningful innovations in digital laparoscopy with Senhance.
“This is the beginning of a new era in digital surgery,” said Dr.
This Intelligent Surgical Unit is compatible with both the global installed base of Senhance Surgical Systems and with third-party vision systems that are currently supported by Senhance.
Senhance Indication for Use
This press release includes statements relating to the Senhance System and the Company’s 510(k) clearance of its Intelligent Surgical Unit that is designed to enable machine vision capabilities on the Senhance Surgical System. These statements and other statements regarding our future plans and goals constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the Intelligent Surgical Unit will be focused on optimizing visualization and camera control in ways never before offered in robotic or digital surgery; and whether the ISU is the beginning of a new era in digital surgery. For a discussion of the risks and uncertainties associated with