Boston Scientific receives FDA clearance for the Asurys™ Fluid Management System

Rhea-AI Summary

Boston Scientific (NYSE: BSX) received FDA 510(k) clearance on March 30, 2026 for the Asurys Fluid Management System, an irrigation and distention system for endoscopic urologic procedures. The device pairs with LithoVue Elite to help monitor and regulate intrarenal pressure (IRP). A limited U.S. market release will begin in the coming days.

The system is intended for ureteroscopy, cystoscopy, percutaneous nephrolithotomy (PCNL) and BPH procedures and is part of the StoneSmart ecosystem.

Positive

• FDA 510(k) clearance for Asurys received on March 30, 2026
• IRP-aware irrigation when paired with LithoVue Elite for real‑time pressure regulation
• Multi-procedure use across ureteroscopy, cystoscopy, PCNL and BPH expands addressable portfolio

Negative

• Limited U.S. market release only, which could delay broad commercial adoption and revenue contribution

News Market Reaction – BSX

-9.02% 1.6x vol

101 alerts

-9.02% Session close to close

-7.5% Trough in 3 hr 27 min

$102.80B Market Cap

1.6x Rel. Volume

In the Mar 30 session, BSX declined 9.02%, reflecting a notable negative market reaction. Argus tracked a trough of -7.5% from its starting point during tracking. Our momentum scanner triggered 101 alerts that day, indicating very high trading interest and price volatility. Trading volume was above average at 1.6x the daily average, suggesting increased trading activity.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved -9.0% in the session following this news. A negative reaction despite FDA 510(k) cle...

Analysis

The stock moved -9.0% in the session following this news. A negative reaction despite FDA 510(k) clearance would fit a recent pattern where even neutral or constructive headlines coincided with mild declines. The stock had already been trading below its 200-day MA of 94.95, suggesting a weaker backdrop before this update. In such a scenario, broader medical device sector softness and prior legal overhangs, rather than this specific kidney stone management launch alone, could have contributed to downside pressure.

Key Figures

Kidney stone incidence: 1 in 10 people

1 metrics

Kidney stone incidence 1 in 10 people Lifetime risk of developing a kidney stone cited in article

Historical Context

5 past events · Latest: Mar 12 (Negative)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Mar 12	Litigation headline	Negative	-1.6%	Lawsuit alleging executives misrepresented U.S. electrophysiology volumes.
Mar 06	Investor conference	Neutral	-2.3%	Planned investor event to discuss ACC clinical data via webcast.
Feb 25	Acquisition-related	Neutral	-2.2%	Penumbra earnings noting proposed acquisition by Boston Scientific.
Feb 23	Board changes	Neutral	-0.3%	Election of Cathy Smith and Christophe Weber to the Board.
Feb 13	Conference participation	Neutral	+0.8%	Participation in TD Cowen health care conference Q&A session.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent BSX headlines, even neutral or positive, have often coincided with modest share declines, suggesting a tendency for the stock to trade lower around news events.

Recent Company History

Over the last several weeks, Boston Scientific news included a lawsuit over U.S. electrophysiology volume disclosures on Mar 12, 2026, multiple investor and conference events in early March, and board refreshment with new directors elected effective Feb 18, 2026. Penumbra’s strong 2025 results also highlighted a proposed acquisition by Boston Scientific. This FDA 510(k) clearance for the Asurys system adds a targeted urology technology milestone to a flow of legal, governance, and strategic updates that have recently coincided with mild share pressure.

Key Terms

ureteroscopy, cystoscopy, percutaneous nephrolithotomy (pcnl), benign prostatic hyperplasia (bph), +4 more

8 terms

ureteroscopy medical

"Ureteroscopy is a common procedure to diagnose and treat problems in the urinary tract"

Ureteroscopy is a minimally invasive procedure in which a doctor threads a thin, flexible camera and small tools up the urinary tube that connects the kidney to the bladder to find and remove kidney stones or treat small growths. Think of it like sending a tiny inspection camera and grabber down a narrow pipe to clear a blockage. Investors care because procedure volumes, device sales, hospital revenue, and reimbursement rates directly affect makers of scopes, surgical tools, and healthcare providers.

cystoscopy medical

"single irrigation management system for ureteroscopy, cystoscopy, percutaneous nephrolithotomy (PCNL)"

A cystoscopy is a medical procedure in which a thin tube with a light and camera is inserted into the bladder through the urethra so a doctor can look directly at the bladder lining and urinary tract. Think of it like sending a tiny inspection camera into a pipe to check for damage, growths, or blockages. For investors, cystoscopy matters because it drives demand for specific medical devices, diagnostic tools, drugs, and follow-up treatments, and changes in procedure volume, reimbursement, or technology can affect companies’ revenues and regulatory prospects.

percutaneous nephrolithotomy (pcnl) medical

"system for ureteroscopy, cystoscopy, percutaneous nephrolithotomy (PCNL) and benign prostatic hyperplasia"

Percutaneous nephrolithotomy (PCNL) is a minimally invasive surgical procedure that removes large or complex kidney stones by creating a small tunnel through the skin into the kidney and using instruments to break up and extract the stone, like using a straw and tiny tools to remove a lodged object. It matters to investors because the volume, cost, and outcomes of PCNL affect demand for specific medical devices, hospital revenue, procedure pricing, and reimbursement policies, making it a factor in the financial performance of device makers, hospitals, and insurers.

benign prostatic hyperplasia (bph) medical

"percutaneous nephrolithotomy (PCNL) and benign prostatic hyperplasia (BPH) procedures"

Benign prostatic hyperplasia (BPH) is a noncancerous enlargement of the prostate gland that can squeeze the urethra and cause urinary symptoms such as weak stream, frequent nighttime urination, or difficulty starting. Investors care because BPH is common in older men, creating steady demand for medications, medical devices, and procedures; changes in treatment options, regulatory approvals, or trial results can affect companies that sell therapies — think of it as a market driven by a widespread, age-related ‘traffic jam’ in the urinary system.

intrarenal pressure (irp) medical

"keeping intrarenal pressure (IRP) low to help promote safe patient care"

Intrarenal pressure is the fluid pressure inside the kidney’s internal channels that carry urine. Think of it like water pressure inside a home’s plumbing: if it’s too high, it can damage pipes and reduce flow; if too low, function is impaired. For investors, changes in intrarenal pressure matter because they affect the safety and effectiveness of drugs, medical devices, and procedures for kidney conditions, influencing regulatory approval, clinical success, and market adoption.

systemic inflammatory response syndrome (sirs) medical

"complications including systemic inflammatory response syndrome (SIRS), sepsis and renal damage"

A systemic inflammatory response syndrome (SIRS) is an aggressive, body-wide reaction to infection, injury, or other triggers in which the immune system and organs behave as if under severe attack — like an overreacting alarm system that can harm healthy tissue. For investors, SIRS matters because it drives demand for critical care, influences trial outcomes and regulatory decisions for therapies, and can quickly alter hospital costs, patient outcomes, and a health company’s financial prospects.

sepsis medical

"complications including systemic inflammatory response syndrome (SIRS), sepsis and renal damage"

Sepsis is a dangerous medical condition in which an infection triggers the body's defenses to damage its own tissues and organs, often leading to organ failure and emergency hospital care. For investors it matters because sepsis drives demand for diagnostics, antibiotics, intensive-care treatments and hospital resources, affects healthcare costs and insurer payouts, and can influence the commercial prospects and valuation of companies developing related tests, drugs and devices.

lithotripsy medical

"better location for lithotripsy or basketing without manual irrigation"

A medical procedure that breaks up kidney and urinary stones into tiny fragments so they can be passed naturally or removed more easily, usually using sound waves, lasers, or small mechanical devices. Investors care because lithotripsy drives sales of specialized machines, disposable parts and hospital procedure revenue, and changes in technology, reimbursement or treatment guidelines can shift demand and profit prospects for device makers, hospitals and insurers.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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New technology designed to provide a single irrigation management system for ureteroscopy, cystoscopy, percutaneous nephrolithotomy (PCNL) and benign prostatic hyperplasia (BPH) procedures

MARLBOROUGH, Mass., March 30, 2026 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the Asurys™ Fluid Management System, designed to provide irrigation and distention during endoscopic urologic procedures, including ureteroscopies.

Experience the full interactive Multichannel News Release here: https://www.multivu.com/boston-scientific/9282251-en-boston-scientific-fda-clearance-asurys-fluid-management-system

Ureteroscopy is a common procedure to diagnose and treat problems in the urinary tract, most commonly kidney stones.¹ Research shows that about one in 10 people will develop a kidney stone at some point in their lives.² One challenge during ureteroscopy is maintaining fluid irrigation flow for clear visualization while keeping intrarenal pressure (IRP) low to help promote safe patient care.^3-5 Elevated IRP may contribute to a range of post-operative complications including systemic inflammatory response syndrome (SIRS), sepsis and renal damage.^6-10

The Asurys System is the latest device in Boston Scientific's StoneSmart™ Solutions ecosystem of products to manage and treat kidney stones. When paired with the LithoVue™ Elite Single-Use Digital Flexible Ureteroscope with IRP monitoring, the Asurys System is designed to aid in procedural IRP management.¹¹

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

Another integrated feature of the Asurys System, when connected to the LithoVue Elite System, includes irrigation control from the scope handle, which is designed to reduce reliance on support staff. By pressing a button on the LithoVue Elite Ureteroscope, physicians can activate the on-demand flush feature to reposition stones into a better location for lithotripsy or basketing without manual irrigation.

"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," said Meghan Scanlon, senior vice president and president, Urology, Boston Scientific. "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."

In addition to ureteroscopies, the Asurys System can be used as an irrigation management option for cystoscopy, percutaneous nephrolithotomy (PCNL) and benign prostatic hyperplasia (BPH) procedures. Limited market release of the device in the U.S. will begin in the coming days.

For more information, please visit www.bostonscientific.com/Asurys or www.bostonscientific.com/StoneSmart.

About Boston Scientific
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our business plans and product performance and impact, clinical trials, and new and anticipated product approvals and launches. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. 

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; geopolitical events; manufacturing, distribution and supply chain disruptions and cost increases; disruptions caused by cybersecurity events; disruptions caused by public health emergencies or extreme weather or other climate change-related events; labor shortages and increases in labor costs; variations in outcomes of ongoing and future clinical trials and market studies; new product introductions; expected procedural volumes; the closing and integration of acquisitions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements, except as required by law. This cautionary statement is applicable to all forward-looking statements contained in this document.

CONTACTS:
Nate Gilbraith
Media Relations
+1 (701) 212-9589
nate.gilbraith@bsci.com

Lauren Tengler
Investor Relations
+1 (508) 683-4479
BSXInvestorRelations@bsci.com

References:

1. National Institute of Diabetes and Digestive and Kidney Diseases. Cystoscopy & Ureteroscopy. Available at: https://www.niddk.nih.gov/health-information/diagnostic-tests/cystoscopy-ureteroscopy. Accessed July 2025.
2. National Kidney Foundation. Kidney Stones. Available at: https://www.kidney.org/atoz/content/kidneystones. Accessed July 2025.
3. Yuen SKK, Zhong W, Chan YS, et al. Current utility, instruments, and future directions for intra-renal pressure management during ureteroscopy: Scoping review by global research in intra-renal pressure collaborative group initiative. Ther Adv Urol. 2025;17.
4. Somani B, Davis N, Emiliani E, et al. Intrarenal pressure monitoring during ureteroscopy: A Delphi panel consensus. Eur Urol Open Sci. 2025;73:43–50.
5. Williams JG, Rouse L, Turney BW, Waters SL, Moulton DE. A lumped-parameter model for kidney pressure during stone removal. IMA J Appl Math. 2020;85:703–723.
6. Tokas T, Herrmann TRW, Skolarikos A, et al. Pressure matters: intrarenal pressures during normal and pathological conditions, and impact of increased values to renal physiology. World J Urol. 2019 Jan;37(1):125-31.
7. Gutierrez-Aceves J, Negrete-Pulido O, Avila-Herrera P. Preoperative Antibiotics and Prevention of Sepsis in Genitourinary Surgery. In Smith AD, Badlani GH, Preminger GM, Kavoussi LR (Eds.), Smith's Textbook of Endourology. New York, NY: Blackwell Publishing Ltd. 2012:38–52.
8. Osther PJS, Pedersen KV, Lildal SK, Pless MS, Andreassen KH, Osther SS, Jung HU. Pathophysiological aspects of ureterorenoscopic management of upper urinary tract calculi. Curr Opin Urol.2016;26:63–69
9. Schwalb DM, Eshghi M, Davidian M, et al. Morphological and physiological changes in the urinary tract associated with ureteral dilation and ureteropyeloscopy: an experimental study. J Urol. 1993 Jun;149(6):1576–85.
10. Zhong W, Leto G, Wang L, Zeng G. Systemic inflammatory response syndrome after flexible ureteroscopic lithotripsy: a study of risk factors. J Endourol. 2015 Jan;29(1):25-8. 
11. Morris, A. S., & Langari, R. (2021). Intelligent sensors. Measurement and Instrumentation, 323–348. https://doi.org/10.1016/b978-0-12-817141-7.00011-6

 

View original content:https://www.prnewswire.com/news-releases/boston-scientific-receives-fda-clearance-for-the-asurys-fluid-management-system-302727718.html

SOURCE Boston Scientific Corporation

FAQ

What did Boston Scientific (BSX) announce on March 30, 2026 about Asurys?

Boston Scientific announced FDA 510(k) clearance for the Asurys Fluid Management System on March 30, 2026. According to Boston Scientific, the device provides irrigation and distention for ureteroscopy and other urologic procedures and will enter a limited U.S. market release in the coming days.

When will the Asurys Fluid Management System be available to hospitals and clinics (BSX)?

Availability begins with a limited U.S. market release starting within days after March 30, 2026. According to Boston Scientific, the company will roll the device out in a controlled release before broader commercial distribution.

How does the Asurys system help manage intrarenal pressure (IRP) during ureteroscopy (BSX)?

The Asurys system can automatically regulate irrigation inflow to help avoid exceeding physician-selected IRP settings. According to Boston Scientific, pairing with LithoVue Elite enables real-time IRP monitoring and automated response to pressure data.

For which procedures is the Asurys Fluid Management System cleared (BSX)?

Asurys is cleared for ureteroscopy, cystoscopy, percutaneous nephrolithotomy (PCNL) and benign prostatic hyperplasia procedures. According to Boston Scientific, it is designed as a single irrigation management option across these endoscopic urologic procedures.

What does FDA 510(k) clearance for Asurys mean for Boston Scientific investors (BSX)?

510(k) clearance allows commercial distribution of Asurys in the U.S., enabling initial sales and adoption. According to Boston Scientific, the device will integrate into the StoneSmart ecosystem, with a limited U.S. release starting in the coming days to begin market uptake.