Monday, October 26, 2026 · Daily editionET --:--:--

MedicalMiniature surgical robot

MIRA

by Virtual Incision

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

5

Stage 5 of 5

Regulator-cleared or mass market

Which rule placed it
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.

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

    Delivered

    In 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

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.

  1. 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).

  2. 4

    Paying customers

    Delivered to customers who pay for it, beyond a trial, or a paid service the public can use.

  3. 3

    Pilot

    Working with a named customer in a real setting, as a trial.

  4. 2

    Pre-orders

    Orders, reservations or deposits taken, with nothing delivered yet.

  5. 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.