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January 23, 2018

FDA clears Medrobotics’ robot-assisted visualisation system

The US Food and Drug Administration has granted marketing clearance to Medrobotics’ transabdominal and transthoracic robotic scope, Flex Robotic System.

The US Food and Drug Administration has granted marketing clearance to Medrobotics’ transabdominal and transthoracic robotic scope, Flex Robotic System.

Medrobotics has designed the device to provide robot-assisted three-dimensional (3D) visualisation during general surgical, gynaecological and thoracic procedures by offering Scarfree access to hard-to-reach anatomy.

The Flex Robotic System employs a steerable and shapeable robotic scope that can be navigated in a near-180° path through a single, small entry point.

The robotic device also offers accessory channels for compatible, flexible surgical instruments.

Medrobotics CEO Samuel Straface said: “With this new FDA indication, the use of Medrobotics’ flexible robotic technology extends beyond natural orifices.

“The robotic device also offers accessory channels for compatible, flexible surgical instruments.”

“This clearance is a vital step in our commitment to minimise the impact of surgery by offering less invasive procedures through a single incision in the abdomen or thoracic cavity versus the multiple incisions that are currently required.”

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The FDA initially approved the Flex Robotic System in July 2015 for use in ENT procedures, and for colorectal surgery in May last year.

The system is indicated for visualisation and accessing surgical sites of oropharynx, hypopharynx, larynx, anus, rectum, and distal colon in adults.

It allows hospitals to deliver minimally invasive surgical care for more patients, while its small footprint and quick set-up time enable easy fits in the majority of operating rooms (ORs) with fast room turns.

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