Medical Device Co. Asensus Surgical Announces 510(k) Submission

Additional Intelligent Surgical Unit features will further extend augmented intelligence leadership in surgery

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 filed a 510(k) submission with the FDA for an expansion of capabilities on the previously cleared Intelligent Surgical Unit™ (ISU™). The ISU is utilized on the Company’s Senhance Surgical System which enables digital laparoscopy.

“The expansion of augmented intelligence capabilities is the next driver of performance in digital surgery,” said Anthony Fernando, Asensus Surgical President and CEO. “This submission is an important milestone in our continued leadership with machine vision and augmented intelligence in surgery. We believe these new capabilities will support surgical planning, decision support and teaching.”

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 allows a surgeon to change the field of view using instruments. The new features would expand to include more advanced features to gather real time data during surgery based on the anatomical structures in the surgical field.

“I am enthusiastic about the new capabilities which will soon be added to the Senhance Surgical System,” said Dr. Amit Trivedi, chair of surgery at Hackensack Meridian Health Pascack Valley Medical Center. “These new features would provide planning tools that haven’t existed before in digital and robotic surgery and allow me to perform more consistent surgery.”

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