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Senhance System Cleared by FDA for Robotic Surgery
FDA news release; 2017 Oct 13
FDA has cleared a new robotically-assisted surgical device (RASD) called the Senhance System (TransEnterix Surgical Inc.) that can help surgeons perform minimally invasive procedures.
- The Senhance System can be used to help improve control of surgical instruments during laparoscopy.
- The RASD facilitates endoscopic manipulation of tissues, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization and retraction during laparoscopic colorectal surgery. It is also indicated in gynecological surgery.
- The 510k clearance is based in part on operative data from 45 patients who underwent colorectal procedures.
- The FDA 510k category means the device has been shown to be substantially equivalent to the da Vinci Si IS3000 robotic device.
US Food and Drug Administration. FDA clears new robotically-assisted surgical device for adult patients. [news release]. Research Triangle Park, NC. October 13, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm580452.htm. Accessed October 17, 2017.
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