The MIRA Surgical System Proceeds to FDA Substantive Review for Market Authorization Under the De Novo Classification Pathway

Virtual Incision Has Achieved a Significant Milestone in Its De Novo Request and is Closer to Potential Commercial Readiness

Virtual Incision Corporation today 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.

Vic Fda Submission Press Release Social Post

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.

“Throughout the history of RAS, only a few companies have managed to reach this significant milestone,” said John Murphy, president, and chief executive officer of Virtual Incision. “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. Our design is disruptive and highly differentiated among the current landscape of available and emerging technologies. We are proud of the data we collected, as it demonstrates the capabilities of MIRA in one of the most complex multi-quadrant abdominal procedures. We also observed many operational efficiencies that make the miniaturized approach so unique and potentially scalable to the millions of patients who could be candidates for RAS each year.”

If Virtual Incision obtains marketing authorization, the company plans to initiate a limited launch of MIRA in select centers across the U.S. These centers will aim to leverage the efficiencies created with MIRA to expand the number of patients they can treat with RAS. Their experiences will serve as best practices for the broader launch. In the longer term, the objective is to enable wide adoption in any healthcare facility for any patient undergoing abdominal surgery.

About the MIRA Surgical System

MIRA is the world’s first miniaturized robotic-assisted surgery (RAS) system. Its small, sleek form factor is designed to offer the benefits of RAS during abdominal surgical procedures without the logistical inefficiencies of traditional mainframe robotics. The easily accessible device weighs approximately two pounds and offers internal triangulation with shoulders, arms, and infinite wrist roll inside of the body. It can be used in any operating room – a dedicated mainframe room is unnecessary. With its drape- and dock-free design and portability, MIRA is quick to set up, clean up, and move between cases. Its conveniently accessible design positions it to be used as a standalone system or a complementary tool for facilities that already own a mainframe. With MIRA, every operating room is RAS-ready. The MIRA Surgical System is an Investigational Device and is not available for sale.

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