Wearables & Devices

Medical Device Co. Asensus Surgical Receives FDA 510(k) Clearance

Asensus Surgical

Instrument platform expected to expand dexterity and add capability to Senhance® Surgical System

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 FDA 510(k) clearance for 5 mm diameter articulating instruments, adding to the Senhance Surgical System technology platform. Articulating instruments offer better access to difficult-to-reach areas of the anatomy by providing two additional degrees of freedom. These instruments have previously received CE Mark for use in the European Union.

“Bringing the benefits of 5 mm articulating instruments to the Senhance Surgical System in the U.S. will widen the clinical utility and value of our platform,” said Anthony Fernando, Asensus Surgical President and CEO. “Combining articulation and haptics with augmented intelligence is a very promising development for Performance-Guided Surgery.”

Asensus Surgical’s technology platform, the Senhance Surgical System, is the first of its kind digital laparoscopic platform that leverages augmented intelligence to provide unmatched performance and patient outcomes through machine learning. Senhance goes beyond the typical surgical robotic systems, providing surgical assurance through haptic feedback, eye-tracking camera control, and 3D visualization, and is the first platform to offer 3 mm instruments. Articulating instruments are the latest addition to the Senhance Surgical System in the United States, further enhancing surgical performance with robotic precision.

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