DEPLOYDatabase

Robot model

Galen Surgical Robot

surgicalcommercialby Galen Robotics

Galen ES is the first cooperatively powered robotic surgical assistant platform, FDA De Novo cleared for ear, nose, and throat (ENT) surgeries.

Track Galen Surgical Robot
Manufacturer
Galen Robotics
Form factor
surgical
Maturity
commercial
Lifecycle
active
Deployments
1

The verified answer

As of Sep 2026, DEPLOY verifies Galen Surgical Robot, a surgical by Galen Robotics (commercial): 1 verified deployment on record. 1 source back the record.

Regulatory status1 FDA De Novo authorization

Galen Surgical Robot holds 1 FDA De Novo authorization, per the DEPLOY registry.

See all 1 filings

Overview

Galen ES is the first cooperatively powered robotic surgical assistant platform, FDA De Novo cleared for ear, nose, and throat (ENT) surgeries. Designed to be easily integrated into current surgical workflows, aiding surgeons in performing minimally invasive procedures. Offered via digital-surgery-as-a-service (per-usage) business model.

Verified vs. claimed

Maturity stage
commercial(Commercially deployed with revenue-generating operations.)
Sources on file
View all sources →

Key facts

Form factor

Surgical robot — cooperatively powered robotic surgical assistant

FDA clearance

De Novo — first ENT surgical robot

Specialty

Ear, nose, and throat (ENT) surgery

Business model

Digital-surgery-as-a-service (per-usage, not upfront purchase)

Manufacturer

Galen Robotics (Baltimore, MD, Johns Hopkins spin-out)

Data & sources

News coverage

1

1 source backing this record.View all →

Pricing

No verified price is on record for Galen Surgical Robot. Physical-AI systems are often sold through enterprise contracts or operated as a service rather than at a public list price.

How DEPLOY tracks pricing

Deployments (1)

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Galen Surgical Robot on the deployment map

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Where Galen Surgical Robot is verified operating. Explore the deployment map by place and type.

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Recent activity

Every change to this record is dated, sourced, and independently verified where marked.

Full change history →

Regulatory filings (1)

Safety record

No incidents on record for Galen Surgical Robot.

Only active incidents are counted. Retracted incidents are excluded from this summary but remain reachable at their canonical URLs.

Sources (1)

  1. https://www.medtechdive.com/news/galen-surgical-robot-de-novo-fda-clearance/694951/

Common questions

What is Galen Surgical Robot?
Galen ES is the first cooperatively powered robotic surgical assistant platform, FDA De Novo cleared for ear, nose, and throat (ENT) surgeries. Designed to be easily integrated into current surgical workflows, aiding surgeons in performing minimally invasive procedures. Offered via digital-surgery-as-a-service (per-usage) business model.
How much does Galen Surgical Robot cost?
Galen Surgical Robot's price is not publicly disclosed. DEPLOY has no verified price on record for Galen Surgical Robot from Galen Robotics. Physical-AI systems like this are often sold through enterprise contracts or operated as a service rather than at a public list price; check the manufacturer for the latest.
Is Galen Surgical Robot actually deployed in the real world?
Yes. Galen Surgical Robot is independently verified in real-world operation on the DEPLOY registry, confirmed at named deployment sites with primary sources: not a concept, render, or demo-only.
Who makes Galen Surgical Robot?
Galen Surgical Robot is made by Galen Robotics, based in Baltimore, MD, USA.
Where is Galen Surgical Robot deployed?
1 verified deployment of Galen Surgical Robot is on the DEPLOY registry, including at Baltimore, MD, USA.
Can you buy Galen Surgical Robot?
Galen Surgical Robot is in commercial deployment and is sold to operators; contact the manufacturer to buy, and see the pricing section for any recorded price.
Is Galen Surgical Robot FDA cleared?
Galen Surgical Robot has 1 regulatory record on the DEPLOY registry: FDA De Novo authorization, cleared. See the Regulatory filings section for each agency source.
What are alternatives to Galen Surgical Robot?
On the DEPLOY registry, comparable surgical robots to Galen Surgical Robot include da Vinci (and Ion), Edge Multi-Port Surgical Robot, Edison Histotripsy System, Stryker Mako SmartRobotics.
How does Galen Surgical Robot compare to da Vinci (and Ion)?
Galen Surgical Robot and da Vinci (and Ion) (Intuitive Surgical · 15 deployments) are both surgical robots on the DEPLOY registry. Galen Surgical Robot has 1 verified deployment on record. Compare both records for specs, safety, deployments, and verified-vs-claimed autonomy.
Is Galen Surgical Robot a top surgical?
On DEPLOY's intelligence score, which blends verified deployments, safety, adoption, media, and IP signals, Galen Surgical Robot ranks in roughly the top 79% of surgical models tracked by the registry.
What is Galen Surgical Robot's maturity stage?
Galen Surgical Robot is at the commercial stage on the DEPLOY maturity ladder (research, prototype, pilot, commercial, production). Commercial stage means production-grade deployments are operating at named customer sites.
Is Galen Surgical Robot safe?
Galen Surgical Robot has no incidents on record in the DEPLOY registry. This does not constitute a safety guarantee; it reflects the incidents DEPLOY has tracked and verified to date.
Methodology: Verified · 1 source (no primary) · last reviewed 2026-08-09

Verification posture

Verified

Low confidence

Review state

Stable

Last reviewed 2026-08-09

Maturity + lifecycle

Maturity stage: commercial

Lifecycle: active

Architectural position

Cohort: surgical

Sources by quality tier

1
secondary-trade-publication
Trade publication

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Galen Surgical Robot.

Recent coverage

Galen Surgical Robot in third-party press

Galen robot gets FDA de novo clearance for ENT surgeries - MedTech Dive

Sep 28, 2023

Power Moves: The latest promotions at Galen Robotics, Mind Over Machines, Downtown Partnership - Technical.ly

Jan 22, 2021