Medrobotics bagged an FDA go-ahead to market its robot-assisted surgical platform for colorectal procedures. The clearance follows a CE mark for the same indication and a previous FDA nod for transoral procedures.
The Raynham, Massachusetts-based devicemaker aims to bring robotic surgery to more patients. Its Flex Robotic System, as the name suggests, uses a flexible scope to allow surgeons nonlinear access to hard-to-reach areas through a single opening—the mouth or anus. This gives surgeons options that may not be feasible with minimally invasive straight instruments.
The surgeon inserts instruments through guide tubes and manipulates the system using a joystick-like controller, the company said. Images from a camera guide the procedure.
“The human gastrointestinal system is full of twists and turns, and rigid surgical robots were not designed to operate in that environment. The Flex Robotic System was,” said CEO Samuel Straface, in the statement. “ … American hospitals, surgeons and patients will be able to enjoy the benefits of the world’s only flexible, surgical robotic platform. It will easily integrate into hospitals due to its mobility and short learning curve.”
The device is approved for otolaryngology and colorectal procedures, but the company wants to expand to gynecological surgery and procedures that use small incisions in the abdomen, according to the statement.
To that end, the company reeled in $20 million in February. The funds will also go toward the development of a next-gen robotic-assisted system.