Johnson & Johnson Wins FDA Nod for Monarch Quest 3 Bronchoscopy Robot

Johnson & Johnson has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Monarch Quest 3, the latest software iteration for the Monarch robotically-assisted bronchoscopy platform.

The software update, according to J&J, further advances planning, navigation, and targeting to help surgeons account for CT-to-body divergence and anatomical changes that can happen during bronchoscopy. In addition to new QUEST capabilities, the release leverages the company’s open digital ecosystem, Polyphonic, enabling clinicians to review procedural data and collaborate through a centralized video library.

Monarch Quest 3 is designed to enhance lung nodule procedures with AI-powered nodule segmentation, improved registration and navigation accuracy, a new 3D Compass overlay for better scope-tip orientation, and broader compatibility with mobile and fixed CBCT imaging systems to support targeting and manage CT-to-body divergence. Together, these enhancements strengthen the platform’s continuous registration and real-time scope-tip tracking while enabling ongoing hardware and software updates.

According to J&J, the Monarch platform is the first flexible, robotically assisted bronchoscopy platform, offering continuous visualization, precise scope control, and navigation and targeting capabilities. Monarch Quest earned an FDA nod last year, and the Monarch platform was used in its first Middle East robotic-assisted bronchoscopy case last month.

Comments from Johnson & Johnson execs

Aleksandra Popovic, Ph.D., president, Monarch, MedTech: “Being first to market carries a responsibility to keep advancing. 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.

Our work doesn’t stop at clearance. 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.”

Gaetane Michaud, M.D., interventional pulmonologist and senior director of medical affairs, MedTech: “This release reflects our ongoing commitment to innovation in robotically‑assisted bronchoscopy. 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.”