J&J’s Monarch robot wins FDA nod for AI software update

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Dive Brief:

  • Johnson & Johnson said Wednesday that new software for its Monarch robotic lung biopsy platform, intended to improve accuracy in reaching suspicious nodules, received 510(k) clearance from the Food and Drug Administration.
  • The Monarch Quest technology uses a Nvidia platform to increase the device’s computational power in real-time by 260% and run artificial intelligence algorithms to help navigate patient airways, J&J said in the announcement.
  • Along with technology from the computer chip giant Nvidia, the software also integrates GE Healthcare’s OEC 3D mobile imaging system during procedures.

Dive Insight:

Among lung biopsy procedures in the U.S., robotically assisted bronchoscopy is a small but fast-growing market, where Intuitive Surgical’s Ion system also competes.

Lung cancer has one of the lowest five-year survival rates because it is often diagnosed at a late stage. If caught early, however, a patient’s chance of survival increases significantly.

Almost half of early-stage lesions are in the lung’s peripheral areas, which are hard to reach with traditional bronchoscopy, J&J said. The Monarch system is designed to help surgeons reach further into the lungs to biopsy nodules.

J&J's Monarch robotic surgery system for bronchoscopy is shown against a gray background.

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With the software update, J&J said the system’s digital capabilities now extend from preoperative planning through intraoperative AI-based navigation and post-operative case data analysis.

The improvements “will really help to pinpoint and diagnose early-stage cancer,” Omar Ibrahim, an interventional pulmonologist at UConn Health who uses Monarch in his practice, said in a statement. 

J&J acquired Monarch in its $3.4 billion acquisition of Auris Health in 2019.

In November, J&J received an investigational device exemption to start a U.S. clinical trial for its Ottava soft tissue surgical robot, which it expects to compete with Intuitive’s market-leading da Vinci system.