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Asensus Surgical receives FDA 510(k) clearance for expansion of machine vision capabilities

Press releases may be edited for formatting or style | September 02, 2021 Operating Room
September 01, 2021 -- RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and patient to pioneer a new era of Performance-Guided Surgery™, today announced that it has received 510(k) clearance from the FDA for an expansion of machine vision capabilities on the previously cleared Intelligent Surgical Unit™ (ISU™). The ISU is utilized with the Company’s SenhanceⓇ Surgical System which enables Digital Laparoscopy.

“We are thrilled to have received FDA clearance for our next generation of augmented intelligence features on the ISU,” said Anthony Fernando, Asensus Surgical President and CEO. “The addition of these pioneering digital capabilities on our existing surgical platform provides real-time intraoperative digital tools to surgeons and underscores our commitment to delivering our vision for Performance-Guided Surgery. This is the latest example of our progress toward delivering on our Surgical Assurance Framework by unlocking the clinical intelligence necessary to enable consistently superior outcomes and a new standard of surgery.”

The current features of the ISU 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, and allow a surgeon to change the visualized field of view using the movement of their instruments. The newest ISU features expand upon these capabilities and introduce more advanced features including: 3D measurement, digital tagging, image enhancement, and enhanced camera control based on real-time data from anatomical structures while performing surgery. This will be the first time any of these features will be clinically available in soft-tissue abdominal surgery.

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“This is a new era in digital surgery,” said Dr. Amit Trivedi, chair of surgery at Hackensack Meridian Health Pascack Valley Medical Center and an active user of the Senhance ISU with over one hundred cases completed utilizing the ISU. “The ability to intraoperatively measure with millimeter accuracy in real-time, place digital tags and know that the system keeps track of the instruments at all times are game-changers in surgery. I am very excited about these new features and the future innovations of the ISU’s digital technologies for surgeons.”

“Utilizing real-time 3D measurement tools would be valuable to evaluate margins and estimate defect sizing,” said Dr. Michael Cook of University Medical Center - New Orleans. “Digital tagging is a major advancement to pinpoint specific anatomical locations during the course of a complex operation that may be utilized as landmarks and teaching aides. Surgical robots have the potential to become decision support tools, and these new features help realize that potential.”

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