Johnson & Johnson’s Monarch Platform Receives FDA Clearance for AI-Enhanced Bronchoscopy

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Johnson & Johnson's Monarch Platform Receives FDA Clearance for AI-Enhanced Bronchoscopy
Credit: Retrieved from Screenshot: Johnson & Johnson

Johnson & Johnson MedTech has announced that its MONARCH™ Platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for MONARCH™ QUEST, an advancement in navigation technology featuring AI-powered algorithms and integration with GE HealthCare’s OEC 3D mobile imaging system.

The MONARCH™ Platform is designed to provide minimally invasive access to and visualization of airways, assisting clinicians in biopsying suspicious lung nodules. Notably, nearly half of early-stage lesions are located in the periphery of the lung, which is challenging to reach with traditional bronchoscopy. The MONARCH™ Platform aims to aid clinicians in achieving early, definitive diagnoses in lung cancer cases, potentially accelerating patient entry into treatment pathways by an average of three weeks.

Aleksandra Popovic, President of MONARCH at Johnson & Johnson MedTech, stated, “Our goal with the MONARCH™ Platform is to change the treatment paradigm for diseases such as lung cancer, where significant unmet needs still remain. MONARCH™ QUEST demonstrates our commitment to delivering meaningful innovation that helps clinicians advance the standard of care for their patients.”

The MONARCH™ QUEST software leverages the full-stack NVIDIA accelerated computing platform, increasing the device’s real-time computational power by 260%. This enhancement enables the system to run complex algorithms designed to enhance accuracy and confidence while navigating the lung. Additionally, the software integrates enhanced navigation with intraprocedural 3D imaging data, potentially improving accuracy in targeting lung nodules.

Dr. Omar Ibrahim, an interventional pulmonologist at UConn Health who utilizes the MONARCH™ Platform, expressed enthusiasm about the updates, stating, “This will really help to pinpoint and diagnose early-stage cancer.”

Johnson & Johnson acquired the MONARCH™ Platform through its $3.4 billion acquisition of Auris Health in 2019, underscoring the company’s commitment to advancing robotic-assisted procedures and AI-driven healthcare innovation.

The MONARCH™ Platform’s digital capabilities now extend from preoperative planning through intraoperative AI-based navigation to postoperative case data analysis, reflecting Johnson & Johnson’s dedication to enhancing the continuum of care in lung cancer diagnosis and treatment.

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