SANTA CLARA, Calif. — August 17, 2026 — Johnson & Johnson today announced U.S. 510(k) regulatory clearance for MONARCH™ QUEST 3, the latest software update for the MONARCH Platform. The update reflects the company’s continued commitment to advancing its first‑to-market robotically-assisted bronchoscopy platform guided by clinician experience and focused on improving confidence during complex procedures. The launch of MONARCH QUEST 3 follows three launches in the past eighteen months demonstrating our dedication to innovation for the MONARCH platform.
The MONARCH Platform is the first flexible, robotically assisted platform for bronchoscopy4. MONARCH QUEST delivers continuous visualization during the procedure, inclusive of navigation to and biopsy of targets under direct vision5,6, an advanced robotically-assisted bronchoscope that gives physicians precise control and stable reach7, and navigation and targeting that accounts for CT-to-body divergence.8 MONARCH QUEST 3 builds on this foundation, further advancing planning, navigation, and targeting to help clinicians account for CT‑to‑body divergence and anatomical changes that can occur during bronchoscopy.
In addition to new QUEST capabilities, this release leverages Polyphonic™, Johnson & Johnson’s open digital ecosystem. Polyphonic for MONARCH can help extend surgical intelligence beyond the procedure by enabling clinicians to review procedural volume data and collaborate with other teams through a centralized video library. Polyphonic for MONARCH organizes each MONARCH case into a consistent, reviewable format — making it easier to revisit procedures, identify key moments, and support learning.
“Being first to market carries a responsibility to keep advancing,” said Aleksandra Popovic, PhD, President, MONARCH, MedTech, Johnson & Johnson. “With MONARCH QUEST 3, we’re continuing to evolve the MONARCH Platform in close partnership with clinicians, applying artificial intelligence, expanding imaging integration, and delivering software enhancements that support greater procedural confidence and precision for patients.”
Advancing navigation through MONARCH QUEST 3
Johnson & Johnson has progressively enhanced its AI-powered planning and navigation capabilities for the MONARCH Platform, while broadening compatibility with widely adopted advanced imaging systems.
MONARCH QUEST 3 is designed to deliver:
- AI‑powered nodule segmentation, designed to automatically generate more accurate nodule boundaries with a single click during pre‑procedural planning1.
- Software enhancements to improve registration and navigation accuracy, helping clinicians maintain confidence as anatomy shifts during the procedure2.
- A new 3D Compass overlay, designed to improve visual orientation between joystick controls and patient anatomy to simplify scope‑tip orientation8.
- Broader compatibility with commonly used mobile and fixed CBCT imaging systems, enabling clinicians to leverage existing imaging infrastructure to help manage CT‑to‑body divergence and improve targeting of lung nodules8*.
Together, these enhancements reinforce the MONARCH Platform’s ability to deliver continuous registration and real‑time scope‑tip tracking relative to patient anatomy throughout robotically‑assisted bronchoscopy procedures.
The first robotically-assisted bronchoscope designed to evolve
As the first robotically assisted bronchoscopy system to market, the MONARCH Platform was designed from the outset as a software enabled platform—capable of evolving over time through iterative hardware and software advancements.
“This release reflects our ongoing commitment to innovation in robotically‑assisted bronchoscopy,” said Gaetane Michaud, M.D., interventional pulmonologist and Senior Director of Medical Affairs, MedTech, Johnson & Johnson. “MONARCH QUEST 3 builds on a series of advancements introduced over the past several years, all focused on helping clinicians navigate with greater confidence and target lung nodules with accuracy.”
“Our work doesn’t stop at clearance,” said Popovic. “MONARCH QUEST 3 is another step in a deliberate, ongoing innovation roadmap designed to help clinicians diagnose lung cancer earlier and more confidently, and to continue raising the standard of care.”
Indications for Use (United States)
The MONARCH™ Bronchoscope and the MONARCH™ Platform and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Important Safety Information
Complications from bronchoscopy may include breathing difficulty, vocal cord spasm, hoarseness, slight fever, vomiting, dizziness, bronchial spasm, infection, low blood oxygen, bleeding from biopsied site, or an allergic reaction to medications. More serious complications from bronchoscopy may include collapsed lung, respiratory failure, hemorrhage, burns, heart attack, or cardiac arrhythmia.
About Surgical Solutions from Johnson & Johnson
Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. For over 100 years, we have helped advance surgical care through our innovative portfolio across wound closure, adjunctive hemostats, surgical stapling and instruments, robotics and digital solutions. Together, with clinicians and healthcare experts around the world we are progressing what’s next in surgery to better solve patient needs in metabolic and cardiovascular disease, cancer, and aesthetics and reconstruction. For more, visit https://www.jnjmedtech.com/en-US/product-family/monarch.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at https://www.jnjmedtech.com/en-US/ null. Follow us at @JNJMedTech and on LinkedIn. Auris Health, Inc. is part of Johnson & Johnson MedTech.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding MONARCH QUEST software. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Auris Health, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Auris Health, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
*Compared to previous generations of MONARCH™ QUEST
References
1. Auris Health, Inc. Technical Review: Nodule Segmentation Algorithm. February 2025.
2. Auris Health, Inc. Technical Review: Vision 6DoF in Initial Registration. July 2025.
3. Auris Health, Inc. Technical Review: Scope Tip Pose Estimation in CBCT Images. March 2025.
4. U.S Food & Drug Administration. 510(k) Premarket Notification. Bronchoscope, flexible or rigid. K152819.
5. Johnson & Johnson and its affiliates. MONARCH Platform User Manual. Aug 2024.
6. Johnson and Johnson and its affiliates. MONARCH, Bronch 2.0 DVAL Report – Functionality Dec. 2019.
7. Johnson and Johnson and its affiliates. MONARCH, Design Verification Report, Dec. 2019.
8. Johnson & Johnson and its affiliates. Project Authorization Charter. Jan 2026.
Media contact:
Lindsey Diaz-MacInnis
ldiazmac@its.jnj.com