Johnson & Johnson (Auris Health)
by Johnson & Johnson (Auris Health)
· Based in United States →
— Pioneering the next era of medical intervention by developing platforms that enhance physician capabilities, evolve minimally invasive techniques, and create new categories of care that redefine optimal patient outcomes.
Regulatory Status Disclosed
Overview
The Johnson & Johnson (Auris Health) Monarch Platform is a medical AI tool that integrates robotics, software, data science, and endoscopy to assist physicians in diagnostic and therapeutic bronchoscopic procedures. It is primarily designed to enable earlier and more accurate diagnosis of small, hard-to-reach nodules in the periphery of the lung, which are often indicative of lung cancer.
- What it does: The Monarch Platform allows physicians to navigate a flexible robotic endoscope into the lungs with improved reach, vision, and control. It combines traditional endoscopic views with computer-assisted navigation based on 3D models of the patient’s lung anatomy, providing continuous bronchoscope vision throughout the procedure. The system facilitates obtaining tissue samples for biopsy from peripheral lung nodules.
- Who it is for: This tool is for pulmonologists and other specialists involved in the diagnosis and treatment of lung conditions, particularly lung cancer. It is utilized in care settings such as hospitals and endoscopy suites for outpatient procedures. The Monarch Platform has also received clearance for use in urology for kidney stone removal procedures, making it a multispecialty robotic solution.
- How it fits a clinical or practice workflow: Physicians use a controller-like interface to guide the bronchoscope. Pre-procedural planning involves generating virtual 3D reconstructions from CT scans and mapping potential pathways to the target nodule. During the procedure, real-time visualization and electromagnetic navigation provide a roadmap to the nodule. The system’s stability and precision aid in reaching deep lung nodules and safely taking tissue samples without incision.
- Notable capabilities: The Monarch Platform offers improved access to peripheral lung nodules that may be difficult to reach with conventional bronchoscopy. It integrates AI features for pre-procedural planning, including automatically generating more accurate nodule boundaries. The system also supports continuous bronchoscope vision and computer-assisted navigation.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Robotic-assisted bronchoscopy
- Advanced navigation and visualization
- 3D mapping of lung anatomy
- Precision targeting of peripheral lung nodules
- Flexible robotic endoscope
- Minimally invasive access
Use Cases
- Biopsy of peripheral lung nodules
- Diagnostic evaluation of lung lesions
- Therapeutic interventions in the lung
- Early detection of lung cancer
What Physicians Need to Know
Evidence Base
The Monarch Platform integrates robotics, micro-instrumentation, endoscope design, sensing, and data science. It combines computer-assisted navigation based on 3D models of the patient's lung anatomy with traditional endoscopic views. The system is designed to help physicians diagnose lung nodules when they are small and more easily treated. Auris Health is committed to building robust clinical evidence to support the Monarch Platform's use in interventional pulmonology.
Clinical Validation Studies
The BENEFIT study, a prospective, multicenter study, evaluated the safety and feasibility of the Monarch Platform for diagnostic and therapeutic bronchoscopic procedures. Early results from the first-in-human study showed the system localized lesions in 92% of cases among 24 patients, with no significant adverse events. Later data from 54 patients demonstrated successful localization in 96.3% of procedures. The overall diagnostic yield in the BENEFIT study was 74.1%, and 70% for lung nodules outside the airway, which compares favorably to 30-40% for non-robotic technology. The study reported pneumothorax in 3.7% of procedures, with chest tube placement required in 1.9%. The TARGET trial, a prospective multicenter study, was launched in December 2019 to further characterize the safety and efficacy of the Monarch Platform. Previous studies (REACH and ACCESS) demonstrated improved reach and high accuracy in cadaveric lungs.
Differential Diagnosis Support
The Monarch Platform is specifically designed to aid in the diagnosis of peripheral pulmonary lesions, particularly small and hard-to-reach lung nodules, which are critical for early lung cancer detection. The system provides continuous bronchoscope vision throughout the procedure, enabling physicians to biopsy difficult-to-reach nodules.
Clinical Workflow Integration
The Monarch Platform utilizes a familiar controller-like interface, similar to a video game controller, for intuitive navigation of the flexible robotic endoscope. It is designed to integrate into real clinic workflows. The system aims to enhance physician capabilities and evolve minimally invasive techniques. Over 1,000 bronchoscopic procedures using the Monarch Platform were performed by August 2019.
Physician Tip
The Monarch Platform offers enhanced precision and control for navigating to and biopsying hard-to-reach lung nodules, potentially leading to earlier and more accurate lung cancer diagnoses. Familiarity with a controller-like interface can make the robotic system intuitive to operate. The continuous vision and computer-assisted navigation provided by the platform can improve confidence in reaching targeted lesions.
Auris Health, as part of Johnson & Johnson Medical Devices Companies, contributes to J&J's broader strategy in digital surgery, complementing other robotic platform technologies in development for general surgery (Verb Surgical) and orthopaedics (Orthotaxy). The Monarch Platform is designed to integrate robotics, micro-instrumentation, endoscope design, sensing, and data science. While the primary focus is on lung cancer, future endoscopic clinical indications are envisioned. The system is designed to fit into existing clinical workflows.
Details
| Category | Clinical Decision Support & Reference, Radiology & Imaging AI |
| Pricing |
Unknown
|
| Free Trial | Unknown |
| Deployment | On-premise (for Auris authentication dashboard, installation in your own infrastructure is an option), Cloud (for Auris Health AI clinical documentation, Firebase infrastructure, Google Cloud security) |
| Mobile App | Yes (Auris Health AI clinical documentation app available on iOS; Auris - Hearing Health app available on Apple App Store; HEINE AURIS app for iPhone) |
| API Available | Unknown |
| Languages | Spanish (for Auris authentication dashboard support) |
| Training | Unknown |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
Cleared AI-estimated Auris Health's MONARCH Platform received FDA 510(k) clearance for diagnostic and therapeutic bronchoscopic procedures in March 2018. In May 2022, it received another 510(k) clearance for endourological procedures, making it the first and only multispecialty, flexible robotic solution for use in both bronchoscopy and urology. In August 2026, the Monarch bronchoscopy robot received FDA clearance for a software update (Quest 3) that adds several new features, including AI tools for pre-procedure planning. |
| SOC 2 | Yes AI-estimated |
| GDPR | Yes AI-estimated |
| Integrations | |
| EHR | Not specified |
| Specialties | Interventional Radiology, Oncology, Pulmonology, Thoracic Surgery |
Social Proof
| Customers | unknown |
| Notable | Mary Lanning Healthcare uses Auris Health's Monarch™ Robot. |
Support & Reliability
| Training Provided | Unknown |
What the Web Says
Johnson & Johnson (Auris Health) is primarily recognized for its Monarch Platform, a robotic bronchoscopy system designed for earlier and more accurate diagnosis of lung cancer. Physicians praise its precision, improved reach, and enhanced visualization for accessing hard-to-reach lung nodules. However, J&J has faced significant legal challenges, including a lawsuit where it was ordered to pay over $1 billion to former Auris investors for breaching merger agreements and fraudulently hindering the achievement of regulatory milestones for other robotic platforms.
Overall: MixedStrengths
- Enables earlier and more accurate diagnosis of lung cancer.
- Provides improved reach, vision, and control during bronchoscopic procedures, accessing difficult areas of the lung.
- Minimally invasive procedure.
- Continuous bronchoscope vision throughout the outpatient procedure.
- AI-powered planning and navigation capabilities with recent software updates.
- Potential for future therapeutic applications beyond diagnosis.
Limitations
- Legal disputes and significant financial penalties due to breach of merger agreements and fraud by J&J regarding other Auris robotic platforms.
- Allegations of J&J diverting resources away from Auris's other robotic surgery projects post-acquisition.
- Concerns about J&J's corporate culture, including potential for cronyism and micromanagement, as seen in broader J&J employee reviews.
- High projected price of the Monarch Platform system.
- Some reported inaccuracies in data recorded by Auris software, though customer support is responsive.
- Competition from other robotic bronchoscopy platforms like Intuitive's Ion and Noah Medical's Galaxy systems.
Based on reviews from: Fierce Biotech, PMC, Inc., MedTech Dive, Reddit, YouTube, RAPS, UChicago Medicine, Justia Law, Capterra, Indeed.com, Legal Dive
Last updated: 2026-08-25
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Press & Coverage
MedTech Dive
Judge orders J&J to pay Auris investors more than $1B for merger violations
A Delaware judge ruled that Johnson & Johnson must pay former Auris Health investors over $1 billion in damages for violating a 2019 merger agreement by not providing resources for regulatory milestones for its iPlatform robotic surgery system and fraudulently preventing a Monarch platform milestone.
2024-09
Fierce Biotech
J&J ordered to pay $1B over fallout from Auris robotic surgery deal
Johnson & Johnson has been ordered to pay over $1 billion in damages to former Auris Health investors after a judge found J&J breached its merger agreement by not dedicating sufficient resources to help Auris meet product development milestones.
2024-09
Citeline Insights
As The Dust Settles, What Can We Learn From The J&J Vs. Auris Case?
This article discusses the implications of the September 2024 court case where Johnson & Johnson was ordered to pay over $1 billion in damages to Auris Health investors, highlighting the importance of earnouts in M&A deals.
2025-02
MedTech Dive
J&J's Monarch robot wins FDA nod for AI features
Johnson & Johnson's Monarch robotic bronchoscopy platform received FDA clearance for its latest software update, MONARCHu2122 QUEST 3, which includes advanced AI features for improved planning, navigation, and targeting in lung cancer diagnosis.
2026-08
Johnson & Johnson
Johnson & Johnson Announces MONARCHu2122 QUEST 3, Advancing the Latest in Robotically-Assisted Bronchoscopy
Johnson & Johnson announced U.S. 510(k) regulatory clearance for MONARCHu2122 QUEST 3, a software update for the MONARCH Platform, enhancing its robotically-assisted bronchoscopy capabilities with AI and expanded imaging integration.
2026-08
Johnson & Johnson
Johnson & Johnson Publishes New Future of Digital Surgery Report to Help Define the Emerging Field of Surgical Intelligence
Johnson & Johnson released a report, 'Surgery's Next Inflection Point: The Rise of Surgical Intelligence,' which explores how connected data, AI, and intelligent systems will transform surgery.
2026-08
Johnson & Johnson
Auris Health Announces Publication of Results from BENEFIT Study of MONARCHu00ae Platform in CHEST
Auris Health announced the publication of results from the BENEFIT study in CHEST, demonstrating the safety and feasibility of the MONARCHu00ae Platform for robotic bronchoscopy in diagnosing peripheral pulmonary lesions.
2021-01
Medium (Bounce Health)
Making Sense of J&J's $3.4B Play for Auris Health
This article analyzes Johnson & Johnson's 2019 acquisition of Auris Health, highlighting its strategic importance for J&J's digital surgery ambitions and the subsequent $1 billion damages ordered in 2024 over unmet earn-outs.
2025-05
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Frequently Asked Questions
Auris Health's Monarch Platform is primarily indicated for bronchoscopy procedures, particularly for the diagnosis and treatment of small, peripheral lung nodules. It integrates with clinical decision support by providing enhanced visualization, navigation, and procedural control, aiming to improve diagnostic yield and treatment precision.
The learning curve for the Monarch Platform varies among physicians but is generally supported by comprehensive training programs offered by Johnson & Johnson. These programs include hands-on training, simulation, and proctoring to help ensure physicians achieve proficiency and adhere to best practices for optimal patient outcomes.
Studies suggest that robotic bronchoscopy with the Monarch Platform offers improved diagnostic yield for peripheral lung nodules compared to conventional bronchoscopy, due to its enhanced maneuverability and precision. It aims to provide a safer alternative to CT-guided biopsy by reducing the risk of pneumothorax and hemorrhage, though comparative efficacy can depend on nodule characteristics and physician experience.
The cost implications of integrating Auris Health technology involve the initial capital investment for the Monarch Platform, along with ongoing costs for maintenance and disposable instruments. While specific pricing models are proprietary, institutions often evaluate the long-term cost-effectiveness based on improved diagnostic yield, reduced complications, and potential for earlier intervention compared to alternative, often more invasive, procedures.
While generally safe, limitations of the Monarch Platform can include its applicability to extremely small or difficult-to-access nodules, and the need for specialized training. Contraindications are typically similar to those for conventional bronchoscopy, such as severe coagulopathy or unstable cardiac conditions. Its use might require additional precautions in patients with compromised respiratory function or those who cannot tolerate prolonged procedures.
Long-term data on patient outcomes and recurrence rates following interventions with the Monarch Platform are continually being gathered through ongoing clinical studies and post-market surveillance. Initial studies have focused on diagnostic yield and immediate procedural safety, with a growing body of evidence emerging regarding long-term efficacy in managing lung nodules and potentially reducing recurrence through more precise diagnosis and treatment.
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| Last Verified: 2026-08-24 | First Added: 2026-08-23