AI-Powered MONARCH QUEST Receives Approval for Lung Biopsies

Johnson & Johnson MedTech received U.S. 510(k) regulatory clearance for MONARCH QUEST, an AI-powered software upgrade for its MONARCH Platform. The upgrade integrates AI and 3D imaging to improve lung nodule biopsies performed by the robotic-assisted bronchoscopy system.

“MONARCH QUEST demonstrates our commitment to delivering meaningful innovation that helps clinicians advance the standard of care for their patients,” says Aleksandra Popovic, President of MONARCH, Johnson & Johnson MedTech. The platform improves lung cancer diagnosis by providing minimally invasive access to hard-to-reach areas, explains the firm.  It was recently approved through the 510(k) clearance process, a regulatory pathway overseen by the US Food and Drug Administration (FDA).

The MONARCH Platform is used for lung examinations and procedures, though bronchoscopy carries potential risks such as breathing difficulty and infection. Johnson & Johnson MedTech stated that it remains committed to safety and effectiveness. 

The software runs on NVIDIA’s RTX computing platform, increasing processing power by 260% for better accuracy. It also enables future AI upgrades as part of Johnson & Johnson’s Polyphonic digital ecosystem, which connects surgical technologies and data. "This will help pinpoint and diagnose early-stage cancer with more confidence," says Omar Ibrahim, Interventional Pulmonologist, UConn Health.