Carnegie Mellon University spinoff company Medrobotics Corp. announced today it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Flex® Robotic System, which is based on the research of CMU Robotics Institute Professor Howie Choset.

A flexible endoscopic system that enables surgeons to access and visualize hard-to-reach anatomical locations, the system extends the benefits of minimally invasive surgery — shorter hospital stays and recovery times — to a broader population of patients. Medrobotics initially has targeted the system for use in head and neck surgery, operating through the mouth.

The FDA clearance marks another high point for Carnegie Mellon and its successful entrepreneurial culture. Startup activity among the university’s faculty, students and alumni has led to the creation of more than 138 companies since 2009. Choset serves as the company’s acting chief technology officer and a partial owner.

“Pittsburgh is the ideal starting point for this technology, with the combination of our robotics expertise at CMU, the medical knowledge at the University of Pittsburgh, and the economic development support from the business community,” Choset said. “In particular, we received great initial support and vision from Jim Jordan at Pittsburgh Life Sciences Greenhouse, which was essential in bringing the system to market.”

Choset developed the surgical robot in collaboration with Alon Wolf, then a post-doctoral researcher and now a faculty member at Technion-Israel Institute of Technology, and Dr. Marco Zenati, then a professor of surgery at the University of Pittsburgh School of Medicine, now at Harvard Medical School. Choset, Wolf and Zenati co-founded Medrobotics as a Carnegie Mellon spinoff in 2005.

Today, the company is based in Raynham, Mass. It received European CE mark clearance in March 2014, which allowed for a limited commercial launch of the Flex® Robotic System in select European markets.

"The Flex® Robotic System is the first and only robot-assisted surgical platform with a flexible scope cleared by FDA for use during transoral procedures," said Samuel Straface, president and CEO of Medrobotics. “The minimally invasive system enables surgical access and visualization in hard-to-reach locations through a single site. Doctors can then complete procedures that might otherwise be difficult, or even impossible, to perform due to inability to visualize or access the site."

For the surgical device, Choset and his research team designed a probe that could bend, but remain rigid. It thus combines the features of a laparoscope — a rigid, straight viewing device often used in minimally invasive surgery — with an endoscope, which is a flexible, non-rigid device for peering inside the body.

Physicians can use a joystick to steer the system around organs or other obstructions. It employs a “follow-the-leader” technique so that as the device is extended into the body, the mechanical linkages that follow behind automatically conform to anatomical curves.

The head of the device features a high-definition video camera. Ports on either side of the camera can accommodate tools for cutting or grasping tissue. Though initially developed and tested for heart procedures, Medrobotics has focused its marketing on head-and-neck surgeries accessed through the mouth.