Johnson & Johnson MedTech has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its MONARCH QUEST system, a robotic-assisted bronchoscopy navigation technology.
MONARCH QUEST is part of the MONARCH Platform, which integrates artificial intelligence (AI) capabilities and a verified interface with the GE HealthCare OEC 3D mobile CBCT Imaging System.
According to Johnson & Johnson, the demand for robotically assisted bronchoscopy is increasing within the US, particularly for lung biopsy procedures.
The MONARCH Platform was the first system of its kind to offer minimally invasive access to airways for visualisation and biopsy of suspicious lung nodules. It is said to play a crucial role in reaching early-stage lesions, often located at the periphery of the lungs, which are typically challenging to access using traditional methods.
Data suggests that nearly half of early-stage lung lesions are situated in hard-to-access areas, complicating diagnosis with standard bronchoscopy. However, the MONARCH system is designed to assist clinicians in achieving a prompt and accurate diagnosis, potentially accelerating patient entry into treatment pathways by up to three weeks on average.
Johnson & Johnson MedTech MONARCH president Aleksandra Popovic said: “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.”
By leveraging AI-powered technology, MONARCH QUEST is expected to enhance bronchoscopy procedures. The system builds upon existing capabilities with an innovative scope-in-sheath design and offers physicians continuous visualisation during procedures.
Its advanced software integrates 3D imaging data during navigation, which may increase precision in targeting lung nodules.
The MONARCH QUEST system utilises the NVIDIA RTX-accelerated computing platform, boosting its real-time processing power by 260%. This allows for the execution of complex algorithms, thereby improving accuracy and reliability when navigating lung structures.
In the US, the platform is authorised to assist in visualisation and access during diagnostic and therapeutic bronchoscopic procedures.
With future expansions planned, MONARCH QUEST aims to enhance its AI functionalities through ongoing software updates as part of its commitment to meeting the growing demand for robotic bronchoscopy. The technology supports preoperative planning, AI-based intraoperative navigation, and post-operative data analysis.
The MONARCH Platform forms a core component of the Polyphonic digital ecosystem from Johnson & Johnson. This ecosystem seeks to connect data from various surgical technologies, robotics, and software solutions globally.
Polyphonic aims to deliver applications and enable secure platform development while providing a marketplace for curated software tools tailored to the needs of healthcare professionals.
Launched in June 2024, Polyphonic seeks to offer versatile software applications that function independently of their data source, delivering critical insights at key moments. Future updates will focus on providing an open development environment alongside a marketplace for tailored digital solutions.
