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Asensus Surgical receives CE mark for expanded machine vision capabilities

Press releases may be edited for formatting or style | January 24, 2023 Operating Room
RESEARCH TRIANGLE PARK, N.C., Jan. 23, 2023 (GLOBE NEWSWIRE) -- Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced receipt of CE Mark for an expansion of machine vision capabilities on the previously cleared Intelligent Surgical Unit™ (ISU™). With this CE Marking, the expanded ISU capabilities are now commercially available across all of the Company’s key geographies, including the European Union, Japan, and the U.S. In addition, this approval included a review of the Senhance® Surgical System platform, making Senhance one of the first robotic surgical systems to be approved through the new, more rigorous EU Medical Device Regulation, or MDR, process.

“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,” said Anthony Fernando, Asensus Surgical President and CEO. “This is a significant milestone for the Company as our filing included a review of the Senhance Surgical System, both software and hardware, under the new, stricter EU MDR process. The fact that Senhance was one of the first robotic platforms to be cleared through the new process, in just under one year, is a testament to both the quality of our team and our technology.”

The newest ISU features introduce more advanced features including: 3D measurement, digital tagging, image enhancement, and enhanced intraoperative camera control based on real-time data.

“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,” said Prof. (Saitama Med. Univ.) Dr. med. Dietmar Stephan of St. Marien-krankenhaus Siegen in Germany. The real-time measurement tools have broad applicability in surgery, and digital tagging will support communication between console and tableside indicating critical structures, e.g. clipping points or staple lines. With these new ISU features, I expect that the Senhance Surgical System will be a technology leader in the field of augmented intelligence in surgical robotics."

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