MedicalMiniature surgical robot
MIRA
MIRA is a surgical robot that weighs about two pounds. Its small arms and camera go inside the belly through one cut, and the surgeon steers them from a nearby console. It is used for bowel (colon) surgery and, since August 2026, cleared for some hysterectomies. Fierce Biotech, 26 Feb 2024
- Evidence
- Independently reported
- Human help
- None reported
- Last milestone
- 25 Aug 2026
01Can I get it?
Yes, in places
- Where it works today
- On sale in the US for colon surgery; gynecology use cleared but not yet launched. Virtual Incision press release, 25 Aug 2026
- Published price
- No published price in our sources.
- Human help
- A surgeon controls the robot's arms with hand controllers and a screen.
02Track record
What has actually happened
Every milestone is dated and links to the page it comes from. Lines marked company-reported rest on the maker's own word.
03Promised vs delivered
What the maker said, and when
Dated targets the maker set in public, against what has happened since.
- Said24 Feb 2024
Sales through a First Access Program at selected US centers
After the De Novo clearance, Virtual Incision said it would start selling MIRA at selected US centers, then add sites over time. Virtual Incision press release, 24 Feb 2024
DeliveredIn August 2026 the company said MIRA is commercially available in the US for colon surgery. It has not said how many hospitals use it.
04Safety and incidents
What has gone wrong
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. FDA recall record, posted 4 June 2025
In clinical trials
1 registered trial
From ClinicalTrials.gov, read every day.
How we placed it
The rule, not an opinion
Stages are worked out by published rules from the dated milestones above. We never rate robots, and no maker can pay to change a stage.
- 5
Regulator-cleared or mass marketThis robot
A regulator has cleared it where approval applies: FDA clearance or approval for a medical robot, a permit to run with no one aboard for a self-driving vehicle, or an FAA approval for routine drone flights. Or: Widely sold: sales in the hundreds of thousands, or a product category you can buy in ordinary shops.
Placed by: The FDA cleared MIRA for benign (non-cancer) hysterectomy through the 510(k) route (K260817), and added needle-holding tools for stitching (20 Aug 2026); The FDA cleared MIRA through the De Novo route (DEN230025) for bowel surgery in adults, the first clearance of a robot this small (23 Feb 2024).
- 4
Paying customers
Delivered to customers who pay for it, beyond a trial, or a paid service the public can use.
- 3
Pilot
Working with a named customer in a real setting, as a trial.
- 2
Pre-orders
Orders, reservations or deposits taken, with nothing delivered yet.
- 1
Demo only
Shown in videos, staged events or a factory, with no units working for customers.
What we couldn't confirm. No count of hospitals or operations found. The company's newsroom lists the first MIRA hysterectomy (July 2024) and a space station trip (early 2024); these were not separately confirmed.
Sources
- 01Fierce Biotech, 26 Feb 2024
- 02Virtual Incision press release, 25 Aug 2026
- 03FDA 510(k) summary K260817
- 04HCA Florida Mercy Hospital release via Bluestem, 31 July 2025
- 05MassDevice, 2 Aug 2022
- 06Virtual Incision press release, 24 Feb 2024
- 07FDA recall record, posted 4 June 2025
Cite this page
Robotics Verdict. “MIRA (Virtual Incision): how far has it got?” roboticsverdict.com/robots/virtual-incision-mira. Checked 19 October 2026.
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