FDA Clearance for the MONARCH QUEST 3 Software Update, Advancing the Latest in Robotically-Assisted Bronchoscopy – Johnson & Johnson

Johnson & Johnson 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 bronchoscopy. MONARCH QUEST delivers continuous visualization during the procedure, inclusive of navigation to and biopsy of targets under direct vision, an advanced robotically-assisted bronchoscope that gives physicians precise control and stable reach, and navigation and targeting that accounts for CT-to-body divergence. 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:

i) AI‑powered nodule segmentation, designed to automatically generate more accurate nodule boundaries with a single click during pre‑procedural planning.

ii) Software enhancements to improve registration and navigation accuracy, helping clinicians maintain confidence as anatomy shifts during the procedure.

iii) A new 3D Compass overlay, designed to improve visual orientation between joystick controls and patient anatomy to simplify scope‑tip orientation.

iv) 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 nodules.

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.

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.”