Post by icemandios on Jul 28, 2021 13:24:35 GMT
Asensus Surgical Receives FDA 510(k) Clearance for Articulating Instruments
Instrument platform expected to expand dexterity and add capability to Senhance® Surgical System
July 28, 2021 09:00 AM Eastern Daylight Time
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 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”
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“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.
About Asensus Surgical, Inc.
Asensus Surgical, Inc. is digitizing the interface between the surgeon and patient to pioneer a new era of Performance-Guided Surgery by unlocking the clinical intelligence to enable consistently superior outcomes and a new standard of surgery. This builds upon the foundation of Digital Laparoscopy with the Senhance Surgical System powered by the Intelligent Surgical Unit™ (ISU™) to increase surgeon control and reduce surgical variability. With the addition of machine vision, augmented intelligence, and deep learning capabilities throughout the surgical experience, we intend to holistically address the current clinical, cognitive and economic shortcomings that drive surgical outcomes and value-based healthcare. Learn more about Performance-Guided Surgery and Digital Laparoscopy with the Senhance Surgical System here: www.senhance.com. Now available for sale in the US, EU, Japan, Russia, and select other countries. For a complete list of indications for use, visit: www.senhance.com/indications. For more information, visit www.asensus.com.
Instrument platform expected to expand dexterity and add capability to Senhance® Surgical System
July 28, 2021 09:00 AM Eastern Daylight Time
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 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”
Tweet this
“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.
About Asensus Surgical, Inc.
Asensus Surgical, Inc. is digitizing the interface between the surgeon and patient to pioneer a new era of Performance-Guided Surgery by unlocking the clinical intelligence to enable consistently superior outcomes and a new standard of surgery. This builds upon the foundation of Digital Laparoscopy with the Senhance Surgical System powered by the Intelligent Surgical Unit™ (ISU™) to increase surgeon control and reduce surgical variability. With the addition of machine vision, augmented intelligence, and deep learning capabilities throughout the surgical experience, we intend to holistically address the current clinical, cognitive and economic shortcomings that drive surgical outcomes and value-based healthcare. Learn more about Performance-Guided Surgery and Digital Laparoscopy with the Senhance Surgical System here: www.senhance.com. Now available for sale in the US, EU, Japan, Russia, and select other countries. For a complete list of indications for use, visit: www.senhance.com/indications. For more information, visit www.asensus.com.