Johnson & Johnson (J&J) has received US FDA 510(k) clearance for MONARCH QUEST 3, the latest software update for its MONARCH robotic-assisted bronchoscopy platform.

The clearance marks the fourth software launch for the MONARCH platform in 18 months, as J&J continues to enhance its robotically assisted technology for the visualisation and access of patient airways during diagnostic and therapeutic bronchoscopy procedures.

MONARCH QUEST 3 introduces enhancements across pre-procedural planning, navigation and imaging integration, with a focus on helping clinicians address CT-to-body divergence and anatomical changes that can occur during bronchoscopy.

A key feature is AI-powered lung nodule segmentation, designed to generate more accurate nodule boundaries during pre-procedural planning. 

The update also includes improved registration and navigation accuracy, along with a new 3D Compass overlay to help clinicians orient the bronchoscope tip relative to patient anatomy.

The software expands compatibility with a range of mobile and fixed cone-beam computed tomography (CBCT) imaging systems, allowing clinicians to leverage existing imaging technologies for lung nodule targeting and management of CT-to-body divergence.

J&J said the update builds on its ongoing development of AI-based planning and navigation capabilities for the MONARCH platform, with product enhancements informed by feedback from clinical users.

MONARCH QUEST 3 also integrates with J&J’s Polyphonic digital ecosystem, which supports procedural review, collaboration and case analysis through a centralised video library. Polyphonic for MONARCH enables cases to be organised in a reviewable format to support clinical learning and teamwork.

Aleksandra Popovic, President, MONARCH, J&J MedTech, said the company has a responsibility to continue advancing the platform as a first mover in robotic bronchoscopy, adding that MONARCH QUEST 3 combines AI, expanded imaging integration and software enhancements aimed at supporting greater procedural confidence and precision.

The FDA clearance comes as J&J continues to expand its MedTech business. In July 2026, the company reported Q2 revenue of around $25.3 billion, up 6.6% year-on-year, with its MedTech business contributing more than one-third of total revenue.