Regulator
The FDA cleared MIRA through the De Novo route (DEN230025) for bowel surgery in adults, the first clearance of a robot this small.
A regulator's decision · Sets MIRA's stage
What the source says
“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.”
What it means
MIRA, from Virtual Incision, is at stage 5 of 5 on our ladder: regulator-cleared or mass market. This event is one of the milestones that placed it there.
Human help: Our sources report it working without human help.
More on MIRA
- Virtual Incision said MIRA is on sale in the US for colon surgery, and that it will announce later when the gynecology use goes on sale.
- The FDA cleared MIRA for benign (non-cancer) hysterectomy through the 510(k) route (K260817), and added needle-holding tools for stitching.
- HCA Florida Mercy Hospital did Florida's first hysterectomy with MIRA, as part of a US clinical study run under FDA rules.
- Virtual Incision recalled software on 3 MIRA systems because a delay between the surgeon's hand controls and the robot arms could make motion on the screen stutter. The FDA rated it Class 2; the recall is completed.
- Virtual Incision said a version of MIRA would be tested aboard the International Space Station.