Monarch Robotic Bronchoscopy (Auris Health / J&J)
Robotic-assisted bronchoscopy platform using electromagnetic navigation for peripheral lung nodule biopsy, developed by Auris Health and acquired by Johnson & Johnson.
What This Technology Is
The Monarch Platform is a robotic-assisted bronchoscopy system developed by Auris Health, a company acquired by Johnson & Johnson in 2019. Like Intuitive's Ion system, Monarch enables physicians to navigate through the airways to biopsy peripheral lung nodules.
System components:
- Robotic endoscope: A flexible scope with a smaller inner catheter that can be advanced through airways
- Controller: Handheld device allowing the physician to articulate the scope tip
- Navigation system: Uses electromagnetic tracking combined with preoperative CT imaging to guide to target locations
- Integrated vision: Camera at the scope tip provides direct visualization of airways
Monarch uses electromagnetic navigation rather than the shape-sensing approach employed by Ion. This represents a different technical approach to the same clinical problem.
Where It Is Deployed
Monarch systems are installed in hospitals and pulmonology practices in the United States and internationally. Primary application is biopsy of peripheral pulmonary nodules for lung cancer diagnosis.
Auris Health originally developed robotic systems with applications beyond pulmonology in mind, including potential urologic applications under the Monarch platform.
Known and Documented Failure Modes
Documented and potential failure patterns:
Navigation accuracy
- Electromagnetic field distortion from metal objects or equipment affecting tracking accuracy
- CT-to-body registration errors
- Target motion with respiration
- Navigation drift over procedure duration
Procedural limitations
- Non-diagnostic biopsy results despite reaching target
- Airway anatomy preventing access to certain nodule locations
- Scope size limiting access to small peripheral airways
Hardware and system
- Scope articulation failures
- Electromagnetic sensor malfunctions
- System software errors
- Visualization limitations in bloody or mucus-filled airways
Complications
- Pneumothorax
- Bleeding
- Respiratory complications
- Procedure termination due to technical failure
Oversight and Regulatory Context
Monarch has FDA 510(k) clearance as a bronchoscopy system. It faces similar regulatory and clinical considerations as competing robotic bronchoscopy platforms:
- Diagnostic yield varies by nodule characteristics and operator experience
- No randomized controlled trials comparing robotic bronchoscopy platforms head-to-head
- Learning curve effects on outcomes
- Cost-effectiveness relative to alternatives remains under study
Why This Matters
The availability of multiple robotic bronchoscopy platforms reflects growing interest in minimally invasive lung diagnosis. For patients, key questions remain:
- Which platform, if any, is most appropriate for their specific nodule?
- What is the track record at their specific institution?
- What are the alternatives and their comparative risks?
Competition between Ion and Monarch may drive improvements, but also creates complexity for patients trying to understand options.
External Resources
- Auris Health — Monarch Platform — Manufacturer information (commercial source)
- FDA MAUDE Database
Related Coverage
Report an Incident
If you have direct knowledge of a Monarch system malfunction, diagnostic failure, complication, or safety concern, you can submit documentation to Safety Ledger.