
FDA Clears Monarch Quest for Bronchoscopy
Johnson & Johnson MedTech announced U.S. 510(k) regulatory clearance for Monarch Quest, the latest advancement in Monarch navigation technology, featuring AI-powered algorithms and a verified OEC Open interface with the GE HealthCare OEC 3D mobile CBCT Imaging System
Robotically assisted bronchoscopy represents a small but fast-growing segment of lung biopsy procedures in the U.S. The Monarch Platform, the first robotically assisted bronchoscopy system to market, provides minimally invasive access to and visualization of airways to help clinicians biopsy suspicious lung nodules. Nearly half of early-stage lesions are located in the periphery of the lung, which is difficult to reach with traditional bronchoscopy. The Monarch Platform can aid clinicians in getting to an early, definitive diagnosis in lung cancer cases, which can help care teams get patients into the treatment pathway an average of three weeks faster.
“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, Johnson & Johnson MedTech. “Monarch Quest demonstrates our commitment to delivering meaningful innovation that helps clinicians advance the standard of care for their patients.”
Leveraging the power of AI for bronchoscopy: Monarch Quest builds on the platform’s stable reach and precision with its unique scope-in-sheath design and continuous vision for the physician. The software also integrates enhanced navigation in the Monarch Platform with intraprocedural 3D imaging data with the potential to improve accuracy in targeting lung nodules. Monarch Quest AI-powered navigation now leverages the full-stack NVIDIA accelerated computing platform, based on NVIDIA RTX, increasing the device’s real-time computational power by 260%, and allowing the system to run complex algorithms to enhance accuracy and confidence while navigating the lung. Monarch Quest also adds more AI capabilities for future software releases as the Monarch Platform grows to meet the demand for robotically assisted bronchoscopy procedures. The digital capabilities in the Monarch Platform now extend from preoperative planning through intraoperative AI-based navigation to help improve accuracy, and post-operative case data analysis. The Monarch Platform is part of the Polyphonic digital ecosystem, which will connect data across world-class surgical technologies, robotics, and surgical software while leveraging the global scale of Johnson & Johnson.
“I’m excited about using the same system in a new capacity and having more confidence in a platform I already know and trust,” said Dr. Omar Ibrahim, an interventional pulmonologist at UConn Health, who uses the Monarch Platform in his practice. “This will really help to pinpoint and diagnose early-stage cancer.”