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Virtual Incision nabs FDA authorization for the MIRA Surgical System as the first miniaturized robotic-assisted surgery device

Press releases may be edited for formatting or style | February 26, 2024 Operating Room
LINCOLN, Neb.--(BUSINESS WIRE)--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.”

Minimally invasive surgery (MIS), a type of surgery that involves smaller incisions, has transformed the surgical care landscape and patient outcomes through decreased pain, reduced complications, and shorter recovery time.1 The introduction of robotic-assisted surgery has further expanded the use and effectiveness of MIS for complex procedures, offering surgeons more precision and control than what is possible with conventional techniques. Despite its advantages, roughly 90 percent of U.S. operating rooms (ORs) are still without access to the technology,2 most often due to complex logistics such as dedicated operating room space, specially trained staff, added steps during setup and turnover, and a substantial cost for the equipment. The “in-a-tray” form factor of miniRAS has the potential to overcome these challenges and could impact millions of U.S. patients each year.

MIRA’s innovative tray-to-table design could offer healthcare facilities the advantages of robotic surgery without requiring them to organize the OR around the device, a current challenge of existing mainframe surgical robots. MIRA’s compact, approximately two-pound (less than one kg) framework is portable and designed to minimize setup time, which could enable any OR to be robot ready within minutes.

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