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Home » Boston Scientific wins FDA clearance for fluid management system

Boston Scientific wins FDA clearance for fluid management system

March 30, 2026 By Sean Whooley

Boston Scientific Asurys fluid management system
The Asurys fluid management system. [Image courtesy of Boston Scientific]
Boston Scientific (NYSE:BSX) announced today that it received FDA 510(k) clearance for its Asurys fluid management system.

Marlborough, Massachusetts-based Boston Scientific designed Asurys to provide irrigation and distention during endoscopic urologic procedures. That includes ureteroscopies, which diagnose and treat problems in the urinary tract, such as kidney stones.

According to the company, maintaining fluid irrigation flow for clear visualization while keeping intrarenal pressure (IRP) low to help promote safe patient care often proves a challenge in ureteroscopy. Asurys offers an option to address this challenge, the company says.

Analysts said at the end of last year that they viewed Asurys as a significant growth driver in Urology for Boston Scientific. It marks the latest addition to the StoneSmart Solutions ecosystem of products at the company. When paired with the LithoVue Elite single-use digital flexible ureteroscope with IRP monitoring, Asurys aids in procedural IRP management.

The Asurys system also features irrigation control from the scope handle to reduce reliance on support staff. By pressing a button on the LithoVue Elite Ureteroscope, physicians can activate the on-demand flush feature. This enables them to reposition stones into a better location for lithotripsy or basketing without manual irrigation.

Asurys can also offer an irrigation management option for cystoscopy, percutaneous nephrolithotomy (PCNL) and benign prostatic hyperplasia (BPH) procedures.

Boston Scientific plans to commence its limited rollout of the now-cleared system in the coming days.

Commentary from Boston Scientific Urology leaders

Dr. Ronald Morton, chief medical officer, Urology, Boston Scientific, said:

“Based on feedback gathered through our work with urologists, we know measuring and managing intrarenal pressure (IRP) while maintaining irrigation flow for visualization is increasingly important. Until now, there has not been a system that can automatically respond to IRP data in real-time. The Asurys Fluid Management System can automatically regulate irrigation inflow to help minimize the potential of exceeding physician-selected IRP settings.”

Meghan Scanlon, SVP and president, Urology, Boston Scientific, said:

“We’re driven to advance urology for the long term by making meaningful improvements to patient outcomes while developing innovative technologies that equip and support care teams. The Asurys Fluid Management System is a clinical solution intended to streamline workflows and ultimately improve the treatment of kidney stone disease, all with the aim of reducing the cognitive burden for endourologists.”

Filed Under: 510(k), Food & Drug Administration (FDA), Men's Health, Regulatory/Compliance, Urology Tagged With: Boston Scientific, FDA

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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