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Virtual Incision Corporation has received FDA 510(k) clearance to use its MIRA Surgical System in benign hysterectomy procedures, expanding the platform beyond its original colectomy indication. MIRA, headquartered in Lincoln, Nebraska, became the world's first miniaturized robotic-assisted surgery (miniRAS) device when it received De Novo authorization for colectomy in February 2024.
The new indication opens the door to one of the highest-volume soft tissue specialties in the US. More than one million American women undergo surgery for benign gynecologic conditions each year, and a minimally invasive approach can shorten hospital stays, reduce blood loss, and lower complication rates compared with open surgery. The clearance was supported by the MIRA Surgical System Hysterectomy IDE Study, a prospective trial run by five surgeons across three US hospitals that confirmed the device's safety and performance in benign hysterectomy.
For Virtual Incision, the clearance validates a staged commercialization strategy built around MIRA's compact, low-footprint design, intended to make robotic-assisted surgery viable not just in major hospital systems but in ambulatory surgery centers and community and rural hospitals. For the broader MedTech space, it marks continued momentum for miniaturized robotics as an alternative to conventional mainframe surgical robots, and a notable expansion of robotic access into women's health, an area company leadership has flagged as historically underserved in minimally invasive robotic surgery.
CEO Jim Alecxih said the technology is "aimed at closing the gap" and giving patients access to robotic surgery "in all sites of care." MIRA remains commercially available in the US for colectomy today; the company has not yet announced a commercial availability timeline for the gynecology indication.
