Urology Devices in 2026: The Race for Kidney Stone, Prostate and Bladder Treatment Technologies

Urology device manufacturers are competing across three commercially important areas: minimally invasive treatment of kidney stones, less invasive procedures for enlarged prostates, and long-term management of bladder dysfunction and urinary incontinence.

The competitive landscape is changing as hospitals evaluate technologies that can improve procedural efficiency, reduce recovery burden and expand treatment options. Manufacturers are also competing for recurring revenue from catheters, stents, consumables, maintenance and procedure-related accessories.

For medical device executives, investors and suppliers, the key question is which technologies are gaining clinical adoption, which companies are building stronger portfolios, and where unmet needs create opportunities for new products and partnerships.

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The Industry in Numbers: Revenue, Product Mix and Recent Approvals

The global urology devices industry covers a wide range of products, from urinary catheters and drainage systems to surgical lasers, endoscopes, prostate treatment platforms and neuromodulation implants.

The data highlight two different commercial models. Consumables can generate repeat purchases tied to procedures and patient management, while capital equipment and newer treatment systems depend more heavily on clinical adoption, hospital purchasing and evidence of improved outcomes.

Leading Urology Device Companies and Their Competitive Positions

This is a product-capability comparison, not a ranked list by global urology revenue or market share.

Kidney Stone Treatment: Competition Is Moving Beyond Basic Instruments

Kidney stone treatment uses a combination of diagnostic imaging, ureteroscopes, lithotripsy systems, retrieval baskets, access sheaths and ureteral stents. Manufacturers compete on visualisation, stone fragmentation, irrigation control, procedural access and equipment reliability.

Boston Scientific reported $2.709 billion in Urology revenue in 2025, with organic sales growth of 4.7%. Its annual report identifies stone management as one of the drivers of the business and highlights its Lumenis Pulse holmium laser systems with MOSES technology.

Recent device activity also shows continued interest in procedural control and less invasive treatment. In March 2026, the FDA cleared Boston Scientific's Asurys Fluid Management System for irrigation and intrarenal pressure management during endoscopic urology procedures, including ureteroscopy and percutaneous nephrolithotomy. In January 2026, the FDA cleared SonoMotion's Break Wave system for treating upper urinary tract kidney stones.

Where the commercial opportunities lie

• Single-use and digital ureteroscopes: Assess demand for improved visualisation, reliable image quality and reduced reprocessing requirements.

• Laser systems and accessories: Evaluate lithotripsy platforms, laser fibres and complementary products used in stone procedures.

• Pressure and irrigation management: Identify technologies that support controlled fluid delivery and procedural monitoring.

• Stents and retrieval devices: Evaluate recurring demand for ureteral stents, guidewires, baskets and access products.

• Service and maintenance: Explore opportunities in equipment servicing, training and technology support.

The key business question is not simply whether kidney stone procedures are increasing. It is which device improvements matter enough to influence surgeon preference, hospital purchasing and total procedure costs.

Benign Prostatic Hyperplasia: A Competitive Race for Less Invasive Treatment

Benign prostatic hyperplasia (BPH) can cause lower urinary tract symptoms, including difficulty urinating, weak urinary flow and frequent urination. Device companies compete to offer treatment options with different procedural requirements, recovery profiles and suitability for prostate anatomy.

Established treatment approaches include resection systems, laser procedures and minimally invasive technologies. Newer systems are competing through differences in tissue removal or ablation, treatment delivery, visualisation and procedural workflow.

Recent regulatory activity

Several decisions in 2025 and 2026 show the variety of technologies competing in this category:

• Rezum: In June 2025, the FDA expanded the indication for Boston Scientific's water-vapour therapy system to include larger prostates, up to 150 cm³.

• Zenflow Spring: The FDA approved the Spring Implant and Delivery System in December 2025 for selected men with obstructive lower urinary tract symptoms secondary to BPH.

• ProVee: The FDA approved Prodeon Medical's prostate treatment system in December 2025.

• Urocross: The FDA cleared the Urocross Expander System in March 2026 for lower urinary tract symptoms associated with BPH.

These devices do not have identical indications or clinical evidence. Their regulatory decisions should not be interpreted as proof that one technology is superior to another.

Business opportunities in prostate health

Device design and delivery systems: Manufacturers can evaluate instruments, implants and delivery technologies that address specific anatomical or procedural requirements.

Clinical evidence and training: Companies need to demonstrate how a product fits into clinical practice and support physicians in adopting new techniques.

Hospital economics: Procedure time, capital requirements, consumable use, length of stay and follow-up needs can influence purchasing decisions.

Distribution partnerships: New entrants may need established distributors, clinical specialists and service partners to access hospitals and urology centres.

For suppliers, BPH is a category where technical differentiation must be connected to a clear clinical use case and a commercially viable route to market.

Bladder Management and Continence: The Recurring-Revenue Opportunity

Urinary catheters, drainage systems, intermittent catheterisation products and continence devices serve patients who need temporary or ongoing support. These products have different purchasing channels from capital equipment because demand may involve hospitals, home healthcare providers, distributors and direct patient supply.

Where companies can compete

• Catheter design: Improve ease of use, comfort, packaging and suitability for different patient needs.

• Infection prevention: Assess product features and clinical evidence relevant to safe catheterisation and drainage.

• Home healthcare: Develop distribution and support models for patients requiring ongoing care outside hospitals.

• Patient adherence: Consider discreet, portable and easy-to-use products that address practical barriers to continued use.

• Supply reliability: Offer dependable availability, quality documentation and consistent delivery to healthcare providers.

Products in this category may generate repeat demand, but margins and differentiation vary. Companies need to assess product pricing, distribution costs, reimbursement and the strength of existing supplier relationships.

Neuromodulation and Digital Urology Are Expanding the Competitive Field

Neuromodulation technologies can be used to manage selected bladder dysfunction and urinary incontinence conditions. These systems may involve implanted devices, stimulation leads, external controllers and follow-up services.

Boston Scientific's 2025 Annual Report reported $2.709 billion in Urology revenue, with sales growth supported in part by its stone management franchise and the acquisition of Axonics, which strengthened its pelvic health and neuromodulation capabilities. Its report also described a planned acquisition of Valencia Technologies to expand into an implantable tibial nerve stimulation device for urge urinary incontinence.

In August 2026, UrologyWatch listed FDA approval of the Revi Extend implantable tibial neuromodulation system for urgency urinary incontinence. The same tracker lists the Neuspera battery-free sacral neuromodulation system among 2025 decisions.

These developments illustrate how urology device companies are expanding beyond traditional instruments into therapies that may require ongoing patient management.

Commercial opportunity: Suppliers can assess leads, electrodes, implant components, external controllers, patient-monitoring systems and specialised services. However, device durability, clinical evidence, implant procedure requirements and follow-up costs are essential to evaluating a viable product opportunity.

AI in Urology: A Real Opportunity, but Evidence Quality Matters

AI is being applied to prostate imaging, image interpretation, pathology and other diagnostic workflows. These tools may help clinicians analyse complex data, but commercial adoption depends on validated performance, clinical utility and integration into existing workflows.

A review published in BJU International in June 2026 examined FDA-authorised AI-enabled devices relevant to urology. It found that 30 of 1,358 devices on the FDA AI-enabled device list reviewed through September 2025 were urology-specific, equivalent to 2.2%. Of those urology-specific devices, 70% were classified under radiology, and prostate imaging accounted for 43.3% of indications.

The review also found gaps in public reporting of study design, external validation and patient demographics.

This is a useful signal for technology developers: the opportunity is not just to develop another AI model, but to establish reliable performance and demonstrate relevance to real clinical decisions.

Commercial priorities for AI developers

• Build datasets that reflect the intended clinical population.

• Validate performance across different institutions and imaging systems.

• Demonstrate how the tool fits into radiology, pathology or urology workflows.

• Establish appropriate regulatory and post-market monitoring plans.

• Show whether the tool improves decision-making, efficiency or another measurable outcome.

For medical device leaders, AI should be assessed as a product and workflow proposition, not simply a software feature.

Key Barriers Facing Urology Device Manufacturers

Clinical adoption: Surgeons may be reluctant to switch from familiar devices unless the new product demonstrates meaningful advantages.

Regulatory requirements: Different countries require different evidence, registration and quality-system documentation.

Hospital procurement: Capital equipment often requires budget approval, training, maintenance arrangements and a clear economic justification.

Reimbursement and affordability: A clinically promising technology may still face limited adoption if hospitals or patients cannot absorb the cost.

Manufacturing and quality: Devices used in endoscopic procedures, implants or sterile applications require dependable quality systems and traceability.

Competition from established suppliers: Leading companies have relationships with hospitals, clinical education programmes and service infrastructure that can be difficult for new entrants to replicate.

The most viable entry strategy is often to focus on a specific unmet need, a complementary product or an underserved customer segment rather than compete across an entire urology portfolio.

Where Healthcare Companies Should Look for Growth Opportunities

For medical device executives, investors and suppliers, five areas deserve detailed competitive assessment:

1. Kidney stone management: Compare ureteroscopes, lithotripsy systems, irrigation technologies, stents and retrieval accessories.

2. BPH treatment: Assess the clinical positioning, regulatory status and commercial requirements of minimally invasive prostate technologies.

3. Bladder management: Evaluate catheters, drainage products, continence devices and recurring supply channels.

4. Neuromodulation: Identify implantable systems, stimulation components and technologies for selected bladder dysfunction conditions.

5. AI and digital urology: Assess validated imaging, pathology and workflow solutions with clear clinical applications.

Before investing, companies should compare competitors' product portfolios, regulatory clearances, clinical evidence, manufacturing capabilities, pricing, distribution networks and target customers.

How Towards Healthcare Supports Urology Device Strategy

Towards Healthcare helps medical device companies evaluate competitors, identify customers and assess opportunities across urology technologies.

Its intelligence services include:

• Urology Devices Master Dataset: Structured company, product and technology intelligence.

• Competitive Quadrant: Comparison of manufacturers by portfolio, capabilities and strategic positioning.

• Customized intelligence dashboards: Tracking of products, companies, technologies and regulatory developments.

• Buyer Identification: Identification of hospitals, urology centres, distributors and potential commercial partners.

• Technology and competitor tracking: Assessment of new launches, clearances and portfolio expansion.

• Go-to-market strategy: Support for product prioritisation, partnerships and geographic expansion.

For urology device businesses, the goal is to identify which product categories have unmet needs, which manufacturers are gaining competitive strength, and where a differentiated product or partnership can create measurable commercial value.

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