TransEnterix Receives FDA 510(k) Clearance for Senhance Ultrasonic System
January 15, 2019 at 05:25 pm IST
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TransEnterix, Inc. announced the Company received FDA 510(k) clearance for its Senhance™ Ultrasonic System. Advanced energy devices, including ultrasonic devices, represent some of the most versatile and critical tools for surgeons in minimally invasive surgery. These instruments deliver controlled energy to effectively ligate and divide tissue, and minimize thermal injury to surrounding structures. The Company’s Senhance Ultrasonic System is now available in the U.S., as well as all countries that accept a CE Mark. The Senhance™ System is the first new abdominal robotic surgery platform to receive FDA clearance since 2000, and is the first and only digital laparoscopic surgical platform to offer the security of haptic force feedback that allows surgeons to feel the forces the instruments generate when handling delicate tissue. It is also the first robotic surgical system to offer reusable instruments that help keep per-procedure costs similar to that of traditional laparoscopic surgeries, as well as 3 mm instruments for microlaparoscopic procedures that enable virtually scarless incisions for patients. These advanced technologies exclusive to Senhance were designed to pave the way to the future of robotic surgery by improving the patient and surgeon experience, while helping to lower per-procedure costs and ultimately healthcare costs in general for hospitals and patients. In the U.S. the Senhance System is cleared for laparoscopic colorectal, gynecological, inguinal hernia and cholecystectomy (gallbladder removal) surgery.
Asensus Surgical, Inc. is a medical device company digitizing the interface between the surgeon and patient to reimagine surgery through Performance-Guided Surgery to enable surgeons to deliver outcomes to patients and establish a new standard of surgery. It operates in one business segment, which is the research, development and sale of medical device robotics to improve minimally invasive surgery. It is developing the LUNA Surgical System, a robotic and instrument system as a foundation of its Digital Surgery solution. These systems shall be powered by the Intelligent Surgical Unit to enhance surgeon control and reduce surgical variability. With the addition of machine vision, Augmented Intelligence, and deep learning capabilities throughout the surgical experience, it intends to holistically address the clinical, cognitive and economic shortcomings that drive surgical outcomes and value-based healthcare. It is also working to incorporate all of this in the LUNA Surgical System.