Virtual Incision, a member of Bio Nebraska, announced that its MIRA Surgical System is under substantive review by the U.S. Food and Drug Administration (FDA) for use in bowel resection procedures.
Announcement from Virtual Incision
Virtual Incision Corporation announced its De Novo request was submitted and is under substantive review by the U.S. Food and Drug Administration (FDA). The submission seeks authorization to market the MIRA Surgical System for use in bowel resection procedures and comes on the heels of Virtual Incision’s completed Investigational Device Exemption (IDE) clinical study.
If granted, MIRA will become the first robotic-assisted surgery (RAS) device to obtain marketing authorization through the De Novo pathway for use in bowel resection procedures, making it a trailblazer in soft tissue robotics. Beyond granting Virtual Incision the ability to commercialize MIRA in the U.S. for its intended use, authorization may lay the foundations for expanded procedural indications, entry into international markets, additional instruments and accessories, and future generations of the surgical system.