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FDA Clears New Robotically Assisted Surgical Device

The U.S. Food and Drug Administration has cleared the Senhance System, a robotically assisted surgical device (RASD) that can help facilitate minimally invasive surgery.

RASD enables a surgeon to use computer and software technology to control and move surgical instruments through one or more tiny incisions in the patient’s body (laparoscopic surgery) in a variety of surgical procedures or operations. The benefits of RASD technology may include its ability to facilitate minimally invasive surgery and assist with complex tasks in confined areas of the body.

The design of the Senhance System allows surgeons to sit at a console unit or cockpit that provides a 3-D high-definition view of the surgical field and allows them to control three separate robotic arms remotely. The end of each arm is equipped with surgical instruments that are based on traditional laparoscopic instrument designs. The system also includes unique technological characteristics: force feedback, which helps the surgeon “feel” the stiffness of tissue being grasped by the robotic arm; eye-tracking, which helps control movement of the surgical tools and laparoscopic-type controls similar to traditional surgical equipment.

The Senhance System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization and retraction in laparoscopic colorectal surgery and laparoscopic gynecological surgery. The system is for use on adult patients by trained physicians in an operating room environment.

The FDA concluded that study data, supported by real-world evidence, along with performance testing under simulated use and worst-case scenario conditions, demonstrated the substantial equivalence of the Senhance System to the da Vinci Si IS3000 device for gynecological and colorectal procedures.

The FDA granted clearance of the Senhance System to TransEnterix Surgical Inc.

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