Virtual Incision Receives FDA Authorization for the MIRA Surgical System as the First Miniaturized Robotic-Assisted Surgery Device

-New category challenges industry standards in soft tissue robotic-assisted surgery and has the potential to expand access to minimally invasive care

-De Novo premarket review pathway establishes initial indication for adults undergoing colectomy procedures and lays the foundation for expansion into other abdominal procedures

LINCOLN, Neb. — February 24, 2024 — Virtual Incision Corporation announced the U.S. Food and Drug Administration (FDA) has granted marketing authorization of the MIRA™ Surgical System (MIRA), the world’s first miniaturized robotic-assisted surgery (miniRAS) device, for use in adults undergoing colectomy procedures. The device was submitted via the FDA’s De Novo Classification process, a rigorous pathway designed to classify novel medical devices with no current legally marketed predicate. FDA authorization was based in part on findings from the company’s U.S. Investigational Device Exemption (IDE) clinical study. The announcement was made by Virtual Incision’s president and chief executive officer, John Murphy, at the SAGES 5th Annual Next Big Thing Innovation Weekend in Houston.

“Today marks a turning point in surgical robotics as we have hit a significant milestone in making miniaturized robotic surgery a reality,” said John Murphy. “For more than a decade, our team has been dedicated to our core mission of making every operating room robot-ready. I’m incredibly proud to see our efforts come to fruition. We extend our gratitude to the FDA for its thoughtful review of MIRA’s technology and our clinical evidence. Whether as a complement to the existing mainframes or as a stand-alone platform, miniaturization has the potential to accelerate the adoption of robotic-assisted surgery.”

You can read the remainder of the press release on Virtual Incision’s website by clicking here, or view a PDF copy of the press release.

Shared by Tyler Stowater, board member of Virtual Incision Corporation