FDA OKs Medrobotics’ robotic system for colorectal surgery

Medrobotics' system is FDA-cleared for transoral and colorectal procedures and the company aims to expand into gynecological and other procedures.

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.


Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

“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.

Suggested Articles

Avidity Biosciences is on a roll—after inking an R&D deal with Eli Lilly and hiring a new CEO, the company is reeling in $100 million.

What the NASH field needs, says Genfit CEO Pascal Prigent, is something like the Hb1Ac test for diabetes.

Dubbed “Project Nightingale,” the efforts were announced amid concerns and federal inquiries into the data’s safekeeping and patient consent for use.