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The Intelligent Surgical Unit powers the Senhance surgical robotic. | Credit: Asensus Surgical
Asensus Surgical has acquired the CE mark for an enlargement of machine imaginative and prescient capabilities with its surgical robotic.
The approval expands machine imaginative and prescient for the beforehand cleared Intelligent Surgical Unit (ISU) of the Senhance system. This regulatory nod makes the expanded ISU capabilities obtainable throughout Europe, Japan and the U.S. The FDA cleared the machine imaginative and prescient capabilities in September 2021.
According to Asensus, the approval additionally makes Senhance one of many first surgical robotic methods permitted by EU MDR.
“We are thrilled to be able to offer these ground-breaking ISU capabilities to surgeons in the EU,” mentioned Asensus President and CEO Anthony Fernando. “Surgeon suggestions from the expanded characteristic set throughout the U.S. and Japan has been super, and we stay up for partnering with new and present clients to assist convey superior real-time intraoperative digital instruments into working rooms all through Europe. This is a major milestone for the corporate as our submitting included a evaluate of the Senhance Surgical System, each software program and {hardware}, beneath the brand new, stricter EU MDR course of.
“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.”
About the Asensus Surgical ISU
ISU responds to the surgeon’s instructions and acknowledges sure objects and places within the surgical discipline.
New options embrace 3D measurement, digital tagging and picture enhancement. It additionally options enhanced intraoperative digital camera management primarily based on real-time information.
Asensus mentioned European approval demonstrates its dedication to delivering its promise of “performance-guided surgery.” It expects the brand new options to offer “meaningful support” to surgeons throughout a spread of procedures.
The firm additionally mentioned new augmented intelligence options leverage the longer term capabilities and potential of the ISU.
“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,” mentioned Dr. Dietmar Stephan of St. Marien-krankenhaus Siegen in Germany. The real-time measurement instruments have broad applicability in surgical procedure, and digital tagging will assist communication between console and tableside indicating important buildings, e.g. clipping factors or staple traces.
“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.”
Editor’s Note: This article first appeared on sister web site MassDevice.