Virtual Incision Wins Approval for IDE Supplement

Virtual Incision’s star in medtech continues to shine. The Lincoln, NE-based company recently won FDA approval for an IDE supplement that would allow it to complete enrollment for its clinical trial.

The company is developing Mira, a miniaturized robotic-assisted surgery platform. FDA granted approval for an IDE of the technology in 2020. The Mira platform is being evaluated for bowel resection procedures.

The IDE supplement approval puts Virtual Incision on track to obtain the clinical evidence needed to bring innovation to the soft tissue surgical robotics industry. Results of the completed study will support MIRA’s upcoming FDA De Novo application for market authorization.

“Mira was created to address the limitations of traditional robotic-assisted mainframe machines. We miniaturized and simplified Mira to make it more accessible, easy to use, and easy to adopt,” said John Murphy, president and chief executive officer of Virtual Incision. “These are the features that will allow surgeons to treat more patients each day. It is encouraging to see Mira demonstrating the potential to help surgeons perform simplified robotic procedures safely and precisely. Completing the final stage of our clinical study will be a key milestone along Mira’s regulatory pathway, and we will continue to focus on clinical excellence to best support the innovation we provide to patients and surgeons.”

The company has been consistently hitting milestones. In June of 2021, MD+DI named Virtual Incision as one of five private medtech companies that was making an impact in the industry.

Virtual Incision closed out 2021 by raising $46 million in a series C round.