J&J MedTech Wins FDA Nod for Monarch Quest Robot-Assisted Bronchoscopy

Johnson & Johnson MedTech has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for Monarch Quest, the latest advancement in the company’s Monarch surgical navigation technology.

Monarch Quest features artificial intelligence (AI)-powered algorithms and a verified OEC Open interface with GE HealthCare’s OEC 3D mobile CBCT imaging system.

The Monarch platform is touted as the first robotically assisted bronchoscopy system to market. It offers minimally invasive access to and visualization of airway to help healthcare professionals biopsy suspicious lung nodules.

J&J MedTech said Monarch can help clinicians get an early, definitive diagnosis in lung cancer cases. This helps care teams move patients into the treatment pathway an average of three weeks faster.

Monarch Quest features a scope-in-sheath design and continuous vision for physicians. Its software integrates advanced navigation with intraprocedural 3D imaging data, which can potentially boost accuracy in targeting lung nodules.

The AI-powered navigation now has the full-stack NVIDIA accelerated computing platform, based on NVIDIA RTX. This increases the device’s real-time computational power by 260% and lets the system run complex algorithms to boost accuracy and confidence while navigating the lung. Monarch Quest also adds more AI capabilities for future software releases.

Its digital capabilities now grow from pre-op planning through intra-op AI-based navigation to improve accuracy and post-op case data analysis. Monarch is part of J&J MedTech’s Polyphonic digital ecosystem, which connects data across surgical technologies, robotics, and surgical software.

“Our goal with the Monarch Platform is to change the treatment paradigm for diseases such as lung cancer, where significant unmet needs still remain,” said Aleksandra Popovic, president, Monarch, J&J MedTech. “Monarch Quest demonstrates our commitment to delivering meaningful innovation that helps clinicians advance the standard of care for their patients.”

About a month ago, the company announced that it has resumed the limited market release of its Varipulse pulsed field ablation (PFA) system in the U.S. after a comprehensive investigation.