Johnson & Johnson (J&J) has received the US Food and Drug Administration (FDA) 510(k) clearance for the MONARCH QUEST 3 bronchoscopy system.
It is the latest software update designed for the MONARCH platform, reflecting the company’s goal to advance its robotically-assisted bronchoscopy system.
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The latest development marks the fourth software launch for the platform in 18 months.
MONARCH is intended to provide flexible, robotically assisted visualisation and access to patient airways for both diagnostic and therapeutic bronchoscope procedures.
MONARCH QUEST 3 introduces further enhancements to planning, navigation and helps clinicians address computed tomography (CT)-to-body divergence and anatomical changes that can occur during bronchoscopy.
The software features AI-powered nodule segmentation intended to allow more accurate nodule boundary generation in pre-procedural planning.
Other enhancements include improved registration and navigation accuracy, and a new 3D Compass overlay to assist clinicians in orienting the bronchoscope tip in relation to patient anatomy.
MONARCH QUEST 3 also increases compatibility with a range of mobile and fixed CBCT imaging systems, intended to help clinicians use existing imaging tools for targeting lung nodules and managing CT-to-body divergence.
J&J stated that the system builds upon its ongoing enhancements to the MONARCH platform’s AI-based planning and navigation capabilities, which have been guided by feedback from clinical users.
The software update also leverages J&J’s digital ecosystem, Polyphonic, which enables procedural review, collaboration and case analysis via a centralised video library.
Polyphonic for MONARCH allows each case to be organised in a reviewable format to support learning and teamwork.
J&J MedTech MONARCH president Aleksandra Popovic said: “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.”
Complications associated with bronchoscopy may include breathing difficulties, infection, low blood oxygen, or more serious issues such as collapsed lung or cardiac arrhythmia, according to the provided safety information.
In July 2026, J&J achieved Q2 revenues totalling around $25.3bn, representing a year-over-year uptick of 6.6%, with J&J MedTech accounting for more than a third of the total.
