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Virtual Incision wins FDA nod for miniature MIRA surgical robot for use in colectomies

Robotic surgery has taken a giant leap towards mainstreaming with the FDA's authorization of Virtual Incision's revolutionary miniaturized system MIRA. The regulatory greenlight marks a watershed for miniaturized robotic-assisted surgery (miniRAS) platforms, widely tipped as the next frontier for scaling laparoscopic operation capabilities.



MIRA's innovative design centers around a self-contained two-pound robot that gets inserted through a single umbilical incision in the abdomen. From this vantage, surgeons can maneuver the robotic arms to conduct multi-quadrant procedures using standard minimally invasive tools. Crucially, this compact form factor eschews the elaborate operating room reconfigurations mandated by today's bulky surgical robots.


Following an extensive investigational study, the FDA has approved MIRA for colectomy procedures in adults under its de novo classification protocol for novel devices. This debut clinical application validates Virtual Incision's over decade-long quest to unlock the full potential of miniaturized robotics for soft tissue surgeries across disciplines.


With regulatory clearance secured, Virtual Incision plans a gradual commercial ramp-up beginning with first-access partnerships at select U.S. centers. In parallel, it is pursuing expanded indications spanning gynecology, urology and general surgery aided by a new design iteration specifically for those complex procedures. Looking ahead, the company aims to cement MIRA as a versatile, cost-effective robotic solution complementing or substituting for today's mainframe surgical robots.


The FDA greenlight comes on the heels of MIRA being selected by NASA for space applications - underscoring its disruptive potential across environments. As next-gen robotic platforms like MIRA cross affordability and portability thresholds, they are poised to turbocharge robotic-assisted surgery's proliferation beyond just a handful of specialty centers today. That democratization promises smarter, minimally invasive treatment for millions globally in the coming years.

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