Johnson & Johnson gains FDA clearance for MONARCH QUEST 3 bronchoscopy system
The new software incorporates AI-powered nodule segmentation, which is designed to generate more precise boundaries around lung nodules during pre-procedural planning.
USA—Johnson & Johnson (J&J) has received US Food and Drug Administration (FDA) 510(k) clearance for MONARCH QUEST 3, the latest software update for its MONARCH robotic-assisted bronchoscopy system.
The update represents the fourth software launch for the MONARCH platform in 18 months, as J&J continues to expand its capabilities for lung disease diagnosis and treatment.
The MONARCH system provides flexible, robotically assisted visualisation and access to patient airways during diagnostic and therapeutic bronchoscopy procedures.
MONARCH QUEST 3 introduces enhancements to procedural planning and navigation while helping clinicians address computed tomography (CT)-to-body divergence and anatomical changes that may occur during bronchoscopy.
CT-to-body divergence refers to differences between a patient’s anatomy as captured in pre-procedure CT images and the anatomy encountered during the procedure.
AI and imaging enhancements
The new software incorporates AI-powered nodule segmentation, which is designed to generate more precise boundaries around lung nodules during pre-procedural planning.
This capability can help clinicians identify and target nodules more accurately before beginning a procedure.
In addition, MONARCH QUEST 3 features improvements to registration and navigation accuracy.
It also introduces a 3D Compass overlay that helps clinicians orient the bronchoscope tip in relation to the patient’s anatomy during navigation.
Furthermore, the software expands compatibility with a range of mobile and fixed cone-beam computed tomography (CBCT) imaging systems.
This integration is designed to allow clinicians to use existing imaging technologies to target lung nodules and manage CT-to-body divergence during procedures.
J&J said the update builds on its continued development of the MONARCH platform’s AI-based planning and navigation capabilities.
The company has incorporated feedback from clinical users to guide the latest enhancements and address procedural needs.
Digital collaboration and case review
MONARCH QUEST 3 also connects with J&J’s Polyphonic digital ecosystem, which supports procedural review, collaboration and case analysis through a centralised video library.
Polyphonic for MONARCH organises individual cases in a reviewable format, allowing clinical teams to revisit procedures and support learning and collaboration.
Aleksandra Popovic, president of J&J MedTech MONARCH, said the company has a responsibility to continue improving the platform as an early market entrant.
She added that MONARCH QUEST 3 advances the system through closer collaboration with clinicians, AI applications, broader imaging integration and software enhancements intended to support procedural confidence and precision.
Safety information and financial performance
According to the provided safety information, bronchoscopy can cause complications including breathing difficulties, infection and low blood oxygen levels.
More serious complications may include a collapsed lung or cardiac arrhythmia.
In July 2026, J&J reported second-quarter revenue of about US$25.3 billion, representing a 6.6% year-over-year increase.
J&J MedTech contributed more than one-third of the company’s total revenue during the quarter.
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