Virtual Incision’s MIRA Robot Completes 1st Hysterectomy

Virtual Incision has completed the first surgery in its clinical study evaluating its miniaturized robotic-assisted surgery (miniRAS) device for benign hysterectomy procedures.

The first surgery was successfully completed at the Geneva University Hospitals by Jean Dubuisson, MD, Ph.D., a gynecologic surgeon and the principal investigator for the MIRA Surgical System Hysterectomy Study.

The hysterectomy study is evaluating MIRA’s safety and performance to robotically assist with benign hysterectomy surgeries. The study’s outcomes are planned to support U.S. and international regulatory submissions for benign gynecologic indications.

MIRA’s tray-to-table design, according to the company, could help healthcare facilities offer robotic-assisted surgery (RAS) without needing them to organize their OR around the equipment. miniRAS has an about two-pound framework, portable enough to make any OR robot-ready in minutes, Virtual Incision claims.

This is MIRA’s second clinical study. The first, under an FDA IDE protocol, supported de novo authorization for colectomy procedures.

“At Virtual Incision, we are anchored in clinical excellence as our first priority,” said Piet Hinoul MD, Ph.D., chief medical officer of Virtual Incision. “We are encouraged by the results of our clinical and preclinical work to date, and we believe that miniaturized robotic-assisted surgery will have broad applications across a wide variety of procedures. We are grateful to the Geneva University Hospital team for their contributions, as well as to the patients who are willing to participate in this important work. We are excited to reach this milestone as part of our mission to make every operating room robot-ready.”

The company said new iterations are currently in design for MIRA to be used in general surgery, urology, and other soft tissue and solid organ surgery.