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Asensus Surgical's Senhance System Receives CE Mark for Expanded Machine Vision Capabilities

Asensus Surgical, a pioneer in the field of robotic surgery, has received the CE mark for an expansion of machine vision capabilities with its Senhance surgical robot. This approval expands the capabilities of the previously cleared Intelligent Surgical Unit (ISU) of the Senhance system, making the enhanced features available across Europe, Japan, and the United States.

The FDA cleared the machine vision capabilities in September 2021, and now European surgeons can benefit from the groundbreaking ISU capabilities offered by Asensus Surgical. The approval also makes Senhance one of the first surgical robot systems approved through the new EU Medical Device Regulation (EU MDR).

Anthony Fernando, President and CEO of Asensus, expressed his excitement about the regulatory milestone, stating, "We are thrilled to be able to offer these ground-breaking ISU capabilities to surgeons in the EU. Surgeon feedback from the expanded feature set across the U.S. and Japan has been tremendous, and we look forward to partnering with new and existing customers to help bring advanced real-time intraoperative digital tools into operating rooms throughout Europe."

The Asensus Surgical ISU is designed to respond to the surgeon's commands and recognize certain objects and locations in the surgical field. The new features include 3D measurement, digital tagging, and image enhancement, as well as enhanced intraoperative camera control based on real-time data. These augmented intelligence features leverage the future capabilities and potential of the ISU, demonstrating Asensus's commitment to delivering on its promise of "performance-guided surgery."

Dr. Dietmar Stephan of St. Marien-krankenhaus Siegen in Germany shared his enthusiasm for the second generation of ISU features, stating, "I have used the first generation of the ISU with the Senhance Surgical System, which seamlessly supports human-machine interaction and endoscopic camera control. This second generation of ISU features will bring surgeon support to a new level." He added that the real-time measurement tools have broad applicability in surgery, and digital tagging will support communication between console and tableside, indicating critical structures such as clipping points or staple lines.

With the CE mark for expanded machine vision capabilities, Asensus Surgical's Senhance System is poised to become a technology leader in the field of augmented intelligence in surgical robotics, providing meaningful support to surgeons across a range of procedures. As the demand for advanced surgical robots continues to grow, Asensus Surgical is committed to delivering cutting-edge technology that enhances the performance and precision of robotic surgery, ultimately improving patient outcomes.

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