Virtual Incision announced that it submitted its MIRA surgical robot to the FDA for de novo clearance review.
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 de novo clearance for bowel resection procedures. Virtual Incision says this would make it a “trailblazer” in soft tissue robotics. Clearance could also lay the foundations for expanded procedural indications, the company said.
Virtual Incision may look to build on de novo clearance 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. It said the specific centers in the limited launch have experiences that serve as “best practices” for a subsequent broad 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.”