The approval expands machine vision for the previously cleared Intelligent Surgical Unit (ISU) of the Senhance system. This regulatory nod makes the expanded ISU capabilities available across Europe, Japan and the U.S. The FDA cleared the machine vision capabilities in September 2021.
According to a news release, the approval also makes Senhance one of the first surgical robot systems approved through EU MDR.
“We are thrilled to be able to offer these ground-breaking ISU capabilities to surgeons in the EU,” said Asensus President and CEO Anthony Fernando. “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. This is a significant milestone for the Ccmpany 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.”
About the Asensus Surgical ISU
ISU responds to the surgeon’s commands and recognizes certain objects and locations in the surgical field.
New features include 3D measurement, digital tagging and image enhancement. It also features enhanced intraoperative camera control based on real-time data.
Asensus said European approval demonstrates its commitment to delivering its promise of “performance-guided surgery.” It expects the new features to provide “meaningful support” to surgeons across a range of procedures.
The company also said new augmented intelligence features leverage the future 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,” said Dr. 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.”