Lincoln, Nebraska-based Virtual Incision seeks authorization to market MIRA for use in bowel resection procedures. The submission follows a completed FDA investigational device exemption (IDE) study. FDA approved the IDE supplement for MIRA in April 2022.
MIRA could become the first robot-assisted surgery device to garner a de novo nod for bowel resection procedures. Virtual Incision says this would make it a “trailblazer” in soft tissue robotics. It could also lay the foundations for expanded procedural indications, the company said.
Virtual Incision may look to build on a de novo nod with entry into international markets, the addition of instruments and accessories and the development of future generations for MIRA.
The company plans for a limited launch in the U.S. if it obtains marketing authorization, establishing best practices for a subsequent broader launch.
John Murphy, Virtual Incision president and CEO, called the company’s design “highly differentiated” in the current landscape. He said MIRA’s operational efficiencies offer scalability to reach the millions of candidates for robot-assisted surgery each year.
“Throughout the history of RAS, only a few companies have managed to reach this significant milestone,” Murphy said. “If we are successful with our submission, the FDA De Novo pathway will establish MIRA in a brand-new medical device category of miniaturized RAS.”
