TransEnterix Announces Submission of 510(k) to FDA for First Machine Vision System in Robotic Surgery
New Technology Would Enable Augmented Intelligence with the Senhance Surgical System
“TransEnterix is the first company to seek
The initial features of the Intelligent Surgical Unit (ISU) are designed to increase control in visualization beyond what has previously been available in digital laparoscopy or robotic surgery. The cleared Senhance System already features unique eye-tracking camera control and the new technology would enable 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.
“Many of us that perform and teach surgery firmly believe that the care of patients will be transformed by augmented intelligence and machine vision capabilities in the future,” said Dr.
This Intelligent Surgical Unit will be compatible with the global installed base of Senhance Surgical Systems, and will be compatible with third-party vision systems that are currently supported by Senhance.
Senhance Indication for use
In the U.S., The Senhance® Surgical System is 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. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use. The device is restricted to sale by or on the order of a physician.
This press release includes statements relating to the Senhance System and the Company’s 510(k) submission with an 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
1Pending 510(k), not available for sale within
Mark Klausner, +1 443-213-0501
Terri Clevenger, +1 203-682-8297