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FDA approves new robotic surgery device

Senhance System backed for colorectal and gynaecological operations

US Food and Drug Administration (FDA)

US regulators have approved a new robotic surgery device for use in colorectal and gynaecological operations.

TransEnterix Surgical’s computer-assisted surgical Senhance System allows surgeons to sit at a console unit or cockpit that provides a 3-D high-definition view of the surgical field.

The three robotic arms they control are equipped with surgical instruments for visualisation and endoscopic manipulation of tissue, including through grasping and suturing.

Robotically-assisted surgical devices (RASDs), although not actually robots because they still require direct human control, can facilitate minimally invasive surgery and assist with complex tasks in confined areas of the body.

Binita Ashar, director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health, said: “Minimally invasive surgery helps reduce pain, scarring and recovery time after surgery.

“RASD technology is a specialised innovation in minimally invasive surgery designed to enhance the surgeon’s access and visualization within confined operative sites.”

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.

The FDA approved TransEnterix’s system for use in adults by trained physicians after the regulator concluded it was substantially equivalent for gynaecological and colorectal procedures to the da Vinci Si IS3000 device, which was launched in 2009 by Intuitive Surgical.

17th October 2017

From: Healthcare

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