Virtual Incision pinches de novo clearance for its MIRA miniaturized surgical robot

After being given the green light for a launch into space, Virtual Incision is also getting the go-ahead down here on terra firma. The company’s miniaturized surgical robot MIRA received a de novo clearance from the FDA this week for procedures to remove parts of the colon following the spread of cancer or other diseases.

The MIRA system is small enough to fit in a standard surgical tray, weighing only two pounds. With a camera and two robotic arms, it is designed to be placed entirely inside the patient’s abdomen and to conduct its work through a single cut in the navel.

“Today marks a turning point in surgical robotics as we have hit a significant milestone in making miniaturized robotic surgery a reality,” Virtual Incision President and CEO John Murphy said in a statement. “For more than a decade, our team has been dedicated to our core mission of making every operating room robot-ready.”

The company estimates that about 90% of operating rooms in the U.S. are not equipped with robotic technology, with the hardware often requiring larger, dedicated spaces and specially trained staff.

But Virtual Incision also has its eyes on places with no operating rooms at all—namely, the International Space Station. A modified MIRA made the trip earlier this year, heading 250 miles up to test out its remote-controlled surgery capabilities as well as its performance in zero gravity.

Back on Earth, the company plans to first deliver the device in a limited number of U.S. health systems before increasing MIRA’s production and chasing regulatory approvals in additional types of surgeries.

“Colectomy is one of the most complex multi-quadrant abdominal procedures with nearly 50% still being performed as open surgery,” said Virtual Incision’s chief medical officer, Piet Hinoul, M.D., Ph.D. “Starting with a difficult multi-quadrant procedure like a colectomy presents an exciting opportunity for us to address a high unmet need before we expand into other indications.”

Those could include uses in gynecology and urology as well as other soft tissue and solid organ procedures, the company said, with studies of MIRA in gynecological procedures planned for 2024. At the same time, Virtual Incision said it plans to unveil a new iteration of its robot tailored to general surgery, with a first-in-human study slated to begin outside the U.S. later this year.