Ethicon’s Monarch Surgical Robot for Urological Procedures Receives FDA Clearance

Today, J&J’s Ethicon announced that its robotic surgery platform, Monarch, officially received FDA 510(k) clearance. Ethicon’s Auris Health subsidy received the FDA clearance for Monarch for its endourological procedures. Officials of Ethicon say it is now the first and only multispecialty, flexible robotic solution for use in bronchoscopy and urology, respectively. 

Ethicon stated in a recent news release that the Monarch robot-assisted surgical platform is designed to enable urologists to reach and visualize areas within the kidney with hyper-precision and control. Monarch’s system offers a singular platform for both ureteroscopic and percutaneous nephrolithotomy (PCNL) procedures. 

“Monarch reduces the complexity of gaining high-quality percutaneous access and aids stone clearance efficiency through simultaneous fragmentation and suctioning of stones with robotic assistance,” University of Southern California professor of clinical urology Dr. Mihir Desai said in the release. “With this platform, many urologists may be willing to expand their practice to include percutaneous access and PCNL procedures, thereby increasing patient access to more effective treatments closer to home.”

The company has stated that several barriers inhibit common use of PCNL, however, Monarch offers a way to overcome such barriers with its unique, minimally invasive technology. Monarch has been available for robot-assisted bronchoscopy procedures since 2018. 

Ethicon said it plans to begin a first-in-human clinical study in late 2022 for the Monarch platform’s endourologic application. This latest FDA clearance for Monarch delivers on its vision to extend the robotic platform’s capabilities across multiple specialties to further allow hospital systems to target two diseases using the singular device. 

For more information on the urological devices market in the U.S., EU & APAC regions, please visit to view iData’s full urological devices report suite.

Via: MassDevice

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