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Portable Ultrasound Bladder Scanner Market Analysis & Forecast: 2025-2032

Portable Ultrasound Bladder Scanner Market, By Product Type (3D Portable Ultrasound Bladder Scanner and 2D Portable Ultrasound Bladder Scanner), By End user (Hospitals, Diagnostic Centers, Clinics, and Ambulatory Surgical Centers), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa)

  • Published In : May 2025
  • Code : CMI3547
  • Pages :145
  • Formats :
      Excel and PDF
  • Industry : Medical Imaging

Portable Ultrasound Bladder Scanner Market Analysis & Forecast: 2025-2032

Portable Ultrasound Bladder Scanner Market size is estimated to be valued at USD 160.4 Mn in 2025 and is expected to reach USD 246.0 Mn in 2032, exhibiting a compound annual growth rate (CAGR) of 6.3% from 2025 to 2032.

 Key Takeaways

  • Based on Product Type, the 3D Portable Ultrasound Bladder Scanner segment is projected to lead the global market with 33.0% share in 2025, owing to its ability to non-invasively assess bladder function.
  • Based on End-User, the Diagnostic Center segment is expected to be the top contributor in the market with largest shares in 2025 due to convenience and accurate way to measure bladder volume.
  • Based on Region, North America is expected to lead the market with a 44.3% share in 2025, owing strong health infrastructure and high prevalence of urological diseases. While, Latin America is anticipated to be the fastest growing region in the forecast period is due to increasing demand for advanced diagnostic tools.

Market Overview

A portable ultrasound bladder scanner is a non-invasive handheld ultrasound device. It is used to measure the amount of urine remaining in the bladder after urination. This procedure provides a quick and accurate assessment of bladder volume which helps in identifying potential issues with the bladder emptying.

A bladder scanner is a portable, hand-held ultrasound device that can perform a quick, easy, and non-invasive scan of the bladder. The scanner has an ultrasound probe and transducer to reflect sound waves from the patient's bladder to the scanner. The data is then transmitted to a computer in the handheld unit to automatically calculate the bladder volume. Bladder scanning is painless for the patient, and eliminates the risks associated with unnecessary catheterization. The entire scan takes only a couple of minutes to complete, and does not require operation by a sonographer, and may prevent unnecessary invasive procedures.

Current Events and their Impacts on the Portable Ultrasound Bladder Scanner Market

Current Events

Description and its Impact

Regulatory Shifts Impacting Market Access

  • Description: EU Medical Device Regulation (MDR) Implementation
  • Impact: Strict compliance requirements may delay product certifications, increase costs for European market entry, and force smaller manufacturers to exit.
  • Description: US FDA’s Proposed Supply Chain Monitoring Mandates
  • Impact: Mandatory shortage reporting could strain manufacturers, divert resources to compliance, and reduce flexibility in addressing regional supply gaps.

Geopolitical Trade Policies and Tariffs

  • Description: US-China Tariff Escalation on Medical Components
  • Impact: 15–20% cost increases for Chinese-sourced components may accelerate nearshoring to Mexico/India, raising short-term production costs for US-bound scanners.
  • Description: EU-US Regulatory Divergence on Shortage Reporting
  • Impact: Asymmetric compliance burdens may fragment global supply chains, complicating multinational manufacturers’ distribution strategies.

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Role of Artificial Intelligence (AI) in Portable Ultrasound Bladder Scanner Market

Integration of artificial intelligence in portable ultrasound bladder scanner is significantly enhancing its capabilities, making it more efficient, user-friendly and accurate. Al algorithms, such as Convolutional Neural Networks (CNNs) are utilized to automatically identify bladder in ultrasound images and calculate its volume. This automation technique aids in reducing the need for manual measurements, streamlining workflows and minimizing human errors.

In January 2025, the EchoNous, the leader in point-of-care ultrasound innovation, launched its Kosmos Bladder, a groundbreaking solution in bladder volume scanning. This technique utilizes AI algorithms to deliver bladder volume measurement with remarkable precision.

Reimbursement Scenario in Portable Ultrasound Bladder Scanner Market

Reimbursement for portable ultrasound bladder scanners is a complex and evolving aspect of healthcare policy. While these devices offer significant benefits in terms of non-invasive diagnostics, their reimbursement status can vary based on several factors including Medicare and Medicaid coverage which do not have any specific reimbursement code for portable ultrasound bladder scanner, private insurance may provide reimbursement but it is subjected to individual policy terms and conditions. In the forecast period, the advocacy towards reimbursement codes and policies is transforming such as development will be enhance the reimbursement consistency and encourage the adoption of the device.

Segmental Insights

Portable Ultrasound Bladder Scanner Market By Product Type

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Portable Ultrasound Bladder Scanner Market, By Product Type- 3D portable ultrasound bladder Scanner- Technological Advancement

The 3D portable ultrasound bladder scanner segment is expected to hold a dominant position in the market in 2025, owing to technological advancements in the field of portable ultrasound scanner. A 3D bladder scanner is particularly beneficial in clinical settings as they provide non-invasive, real-time bladder measurement, reducing the need to catheterization and associated risks such as urinary tract infections. This device is utilized in various medical settings including urology clinics, emergency departments, postoperative care, and long-term care facilities.

In May 2024, Butterfly Network introduced the iQ+ Bladder, a portable ultrasound device which is designed for bladder volume measurement. Utilizing Ultrasound-on-Chip technology, the iQ+ Bladder offers advanced bladder 3D visualization capabilities and user-friendly interface. This is further positively influencing the portable ultrasound bladder scanner market forecast.

Portable Ultrasound Bladder Scanner Market, By End User- Diagnostic Centers- Increasing Usage of the Device Drives the Growth

The diagnostic centers segment is expected to hold a dominant position in the portable ultrasound bladder scanner market in2025, owing to increasing usage of portable ultrasound bladder scanner. The primary diagnostics center use of portable ultrasound bladder scanner is as a diagnostics aid. It is mostly operated a healthcare professional nurse, administrating the device to measure the PVR volume and prevent unnecessary catheterization. These devices in diagnostic centers holds the potential to improve the diagnosis and differentiate urological problems and their management and treatment. There are 473 verified diagnostics clinics worldwide. In 2023, India had over 52,000 diagnostics labs in tier one cities and 41,00 in tier three cities. This is further accelerating the portable ultrasound bladder scanner market share.

Regional Analysis

Portable Ultrasound Bladder Scanner Market Regional Insights

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North America Portable Ultrasound Bladder Scanner Market Analysis & Trends

North America is estimated to hold a dominant position in the overall market over the forecast period. North America is estimated to hold 44.3% of the market share in 2032. Rising prevalence of urological bladder cancer boosts demand for the portable ultrasound bladder scanner. For instance, according to the Urology Times report, in 2024, there were 82,290 new cases of bladder cancer and 16,710 deaths in the U.S., in 2025, the number estimates 84,870 new cases and 17,420 deaths. Bladder cancer is considered the sixth most common cancer in the US. An early detection of bladder cancer through urine cytology and cystoscopy can significantly improve survival rates. A portable ultrasound bladder scanner provides with an advanced imaging which increases the role in diagnosis, staging and follow up of bladder cancer, which is further enhancing the portable ultrasound bladder scanner market growth.

Latin America Portable Ultrasound Bladder Scanner Market Analysis & Trends

The Latin America region is expected to exhibit the fastest growth in the market in 2025. The region is experiencing a rapid growth due to increasing awareness of urological disorders and the need for early detection of diseases. The Latin America is implementing various strategies in order to increase awareness of urological disorders, including public awareness campaigns, educational programs within healthcare facilities and partnerships with the patient advocacy groups. For instance, in March 2024, Chile, the Sociedad Chilena de Urologia played a crucial role in advancing urological practices with the help of organized conferences, workshops, and networking events.

Portable Ultrasound Bladder Scanner Market Outlook for Key Countries

U.S. Portable Ultrasound Bladder Scanner Market Analysis and Trends

The United States is the leading region from North America towards portable ultrasound bladder scanner market. The country is driven by its advancement in medical technology, aging population and increasing demand for non-invasive diagnostic tools. Among advanced technology, the United States has 3D imaging and AI-powered analysis. For instance, in January 2025, Clarius Bladder AI, received its 510(k) clearance from the U.S. food and Drug Administration (FDA). This non-invasive tool that automatically measures bladder volume in seconds is available in the United States with the Clarius PAL HD3, Clarius PA HD3 and Clarius C3 HD3 wireless handheld ultrasound scanners.

Brazil Portable Ultrasound Bladder Scanner Market Analysis and Trends

Under Latin America, Brazil is the leading country for portable ultrasound bladder scanner market. The market in Brazil is fueled by the increases number of incidents of urological disorders which includes urinary tract injection (UTIs), bladder stones, and benign prostatic hyperplasia (BPH). These conditions require a necessitate accurate and timely diagnosis, contributing to the growth of portable ultrasound bladder scanner. For instance, a nationwide study revealed that approximately 75% of adults aged 40 and above in major Brazilian cities experience LUTS, with symptoms such as frequent urination, urgency, and nocturia. The prevalence was higher in women (82%) compared to men (69%). This further propels the demand for efficient and portable devices.

Global Portable Ultrasound Bladder Scanner Market Trends

Technological advancements

The advanced technologies in ultrasound are leading to the development of compact, high resolution, and user-friendly portable scanner device. This device is embedded with features such as real-time volume calculation, automated bladder recognition, and wireless connectivity are improving its usability and accessibility.

Aging population

The global aging population is more susceptible to urological disorders, which requires regular monitoring of bladder function. A use of portable ultrasound bladder scanner can provider a convenient and non-invasive method for diagnosing and managing this condition, supporting the growing healthcare needs for the elderly population.

Government initiatives and healthcare accessibility

Government is investing into healthcare infrastructure, particularly in rural area and under reserved region. This initiative is promoting the adoption of portable medical technologies which will enhance healthcare accessibility and encourage the utilization of advanced diagnostic tools such as portable ultrasound bladder scanners.

Global Portable Ultrasound Bladder Scanner Market Driver

Rising Prevalence of Urological Diseases

Rising prevalence of urological diseases is expected to drive the global portable ultrasound bladder scanner market growth over the forecast period. The factors that are driving the market growth are the rising urological diseases, technological advancements, and growing adoption of non-invasive diagnostic procedures. For instance, according to an article published by the National Cancer Institute (NCI) in December 2022, 81.1 thousand new cases of bladder cancer were recorded with 61.7 thousand cases in men and 19.4 thousand cases in women in Year of 2021 in the U.S.

Increasing awareness of urological disease

The virtue of portability is driving up demand for bladder scanners. Additionally, increased urological disease awareness is driving up demand for portable ultrasound bladder scanning operations. The global market for portable ultrasound bladder scanners is anticipated to grow as demand for non-invasive, painless procedures rises. For instance, in May 2025, American Urological Association (AUA) annual meeting was conducted at the Desai Sethi Urology Institute (DSUI), part of the University of Miami Miller School of Medicine. AUA2025 is the world’s largest urology meeting which urologist discuss the issues impacting patients and AUA drives quality care with guideline and scientific statements. There are more than 23,00 members worldwide in AUA.

Global Portable Ultrasound Bladder Scanner Market Restraint

Product recall by regulatory authority

The Regulatory authorities have recalled products that don’t adhere to sufficient quality or safety standards, restraining the markets expansion. For instance, in December 2020, Verathon Inc. is a medical device company, recalled its bladder scan prime plus probe owing to a change in the handle material and manufacturing method that could cause the probe handle to shatter. This probe is used to measure the volume of urine in the bladder non-invasively. Such recalls by regulatory requirements are limiting market. Companies are focusing on the quality and manufacturing process of the products.

Global Portable Ultrasound Bladder Scanner Market Opportunity

The future of portable ultrasound bladder scanner market forecast indicates expanding rapidly though innovations in healthcare delivery, rising number of disease and a growing focus towards a cost-effective approach to diagnose issues. Along from AI and machine learning technologies, there will be incorporation of telemedicine and remote monitoring technique which will positively influence the rural and home-based care. This approach will reduce hospital visits for patients suffering from chronic urological conditions.

Market Report Scope

Portable Ultrasound Bladder Scanner Market Report Coverage

Report Coverage Details
Base Year: 2024 Market Size in 2025: USD 160.4 Mn
Historical Data for: 2020 To 2024 Forecast Period: 2025 To 2032
Forecast Period 2025 to 2032 CAGR: 6.3% 2032 Value Projection: USD 246.0 Mn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Product Type: 3D portable ultrasound bladder scanner, 2D portable ultrasound bladder scanner 
  • By End user: Hospitals, Diagnostic Centers, Clinics, Ambulatory Surgical Centers 
Companies covered:

C. R. Bard, Inc. (Becton, Dickinson and Company), dBMEDx Inc., Healcerion Co., Ltd. , Verathon Inc., SRS Medical Systems Inc., Laborie Medical Technologies Inc., Lilium Otsuka Co. Ltd,  Echo Son SA, Signostics Inc., Sonostar Technologies Co., Limited, Caresono Technology Co., Ltd., EchoNous, Roper Technologies, Inc., canon medical systems corporation , Koninklijke Philips N.V. , Siemens Healthcare GmbH, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. ,alpinion medical systems co.,  Samsung healthcare and GE Healthcare Inc.

Growth Drivers:
  • High prevalence of urological diseases 
  • Increasing awareness of urological disease
Restraints & Challenges:
  • Product recall by regulatory authority

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Key Developments

  • In April 2025, Clarius Mobile Health, a pioneer in AI-powered handheld ultrasound, launched its Clarius Prostate AI, an FDA approved semi-automated tool that quickly and accurately calculates prostate volume during an ultrasound exam. Clarius demonstrated Prostate AI at the American Urological Association annual meeting in Las Vegas.
  • In March 2025, Research published in Urology states, reseachers from the Alexandria School of Medicine in Egypt have found out that, Fluoroscopy-assisted ultrasound guidance for mini-percutaneous nephrolithotomy (mini-PCNL) procedures in children is a safer and more effective approach than fluoroscopy alone. The results show that there is a way to treat children with kidney stones with lower radiation doses.
  • In January 2025, the FDA granted 510(k) clearance to the RELIEF ureteral stent for the prevention of vesicoureteral reflux, University Hospitals in Cleveland, Ohio. The stent's design minimizes bladder spasms and reflux, improving patient comfort compared to standard stents.
  • In April 2024, GE Healthcare introduced the AI-driven Caption AI software on Vscan Air SL, a handheld, wireless ultrasound imaging system. This product line includes more than 50,000 systems used by clinicians.

Analyst Opinion (Expert Opinion)

  • GE Healthcare’s strategic acquisition of Intelligent Ultrasound’s AI assets marks a pivotal move in the race to dominate the high-end diagnostic ultrasound segment. GE poised to capture up to 25% of the high-end portable bladder scanner segment by 2027. This consolidation places increased competitive pressure on smaller and mid-sized innovators, who may struggle to keep pace without equivalent AI infrastructure or R&D scale. It is expected that this development will force a bifurcation in the market: premium AI-integrated solutions led by dominant global OEMs, and value-based scanners focused on price-sensitive emerging markets.
  • Simultaneously, regulatory changes in China are reshuffling global supply chains. The National Medical Products Administration (NMPA) has recently introduced stricter digital validation and compliance standards for all Class II and III medical devices intended for export—including portable bladder scanners. These updated guidelines mandate enhanced documentation of software validation, digital traceability, and real-time data integrity protocols. The immediate implication is a regulatory bottleneck, with expected delays of 4–6 months for China-manufactured scanners to clear export approval. However, it concurrently opens a strategic window for Southeast Asian competitors notably from Vietnam, Malaysia, and Thailand to accelerate market entry by offering regulatory agility, lower lead times, and increasingly competitive pricing.

Detailed Segmentation

  • Global Portable Ultrasound Bladder Scanner Market, By Product Type:
    • 3D Portable Ultrasound Bladder Scanner
    • 2D Portable Ultrasound Bladder Scanner
  • Global Portable Ultrasound Bladder Scanner Market, By End User:
    • Hospitals
    • Diagnostic Centers
    • Hospitals
    • Diagnostic Centers
  • Global Portable Ultrasound Bladder Scanner Market, By Region:
    • North America
      • U.S.
      • Canada
    • Latin America
      • Brazil
      • Mexico
      • Argentina
      • Rest of Latin America
    • Europe
      • Germany
      • U.K.
      • France
      • Italy
      • Spain
      • Russia
      • Rest of Europe
    • Asia Pacific
      • China
      • India
      • Japan
      • Australia
      • South Korea
      • ASEAN
      • Rest of Asia Pacific
    • Middle East
      • GCC
      • Israel
      • Rest of Middle East
    • Africa
      • South Africa
      • Central Africa
      • North Africa
  • Key Players
    • C.R. Bard, Inc. 
    • dBMEDx Inc.
    • Healcerion Co., Ltd.
    • Verathon Inc.
    • SRS Medical Systems Inc.
    • Laborie Medical Technologies Inc.
    • Lilium Otsuka Co. Ltd
    • Echo Son SA
    • Signostics Inc.
    • Sonostar Technologies Co., Limited
    • Caresono Technology Co., Ltd.
    • EchoNous, Roper Technologies, Inc.
    • Canon medical systems corporation
    • Koninklijke Philips N.V.
    • Siemens Healthcare GmbH
    • Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
    • Alpinion medical systems co.
    • Samsung healthcare
    • GE Healthcare Inc.

Sources:

Primary Research Interviews from the following stakeholders:

Stakeholders:

  • Interviews with medical device manufacturers, urologists, diagnostic imaging professionals, hospital procurement teams, and portable device distributors across key global healthcare markets.

Specific stakeholders:

  • Procurement heads at hospital groups and health systems (e.g., HCA Healthcare, Mayo Clinic, NHS Supply Chain)
  • Biomedical engineers and clinical technology managers at tertiary hospitals (e.g., Cleveland Clinic, AIIMS)
  • Product managers from medical device OEMs (e.g., manufacturers of ultrasound and diagnostic systems)
  • Diagnostic imaging center directors in urban and semi-urban areas (e.g., São Paulo, Mumbai, Bangkok)
  • Clinic operators and urologists in high-volume outpatient settings across North America, Europe, and Latin America

Databases:

  • U.S. Food and Drug Administration (FDA) MAUDE and 510(k) databases
  • European Commission EUDAMED device database
  • World Health Organization (WHO) Global Health Observatory
  • Brazilian Unified Health System (DATASUS)
  • Japan Medical Devices NDB Open Data

Medical Journals & Academic Sources:

  • The Journal of Urology
  • BMJ Open
  • Indian Journal of Urology
  • International Urogynecology Journal
  • Journal of Medical Imaging and Health Informatics

Magazines & Industry Media:

  • MedTech Insight
  • DOTmed HealthCare Business News
  • Diagnostic Imaging Europe
  • Healthcare Purchasing News
  • BioSpectrum Asia

Newspapers & Business Press:

  • The Wall Street Journal (Health section)
  • The Hindu Business Line – Healthcare & Pharma
  • El Financiero – Health Technology
  • Valor Econômico – Saúde
  • Nikkei Asia – HealthTech

Professional Associations & Health Agencies:

  • American Urological Association (AUA)
  • Brazilian Society of Urology (SBU)
  • European Association of Urology (EAU)
  • Radiological Society of North America (RSNA)
  • World Federation for Ultrasound in Medicine and Biology (WFUMB)
  • Pan American Health Organization (PAHO)

Public Domain Sources:

  • Centers for Medicare & Medicaid Services (CMS) – U.S. Reimbursement Schedules
  • National Health Service (UK) Procurement Reports
  • OECD Health Statistics
  • Global Health Expenditure Database (WHO)
  • UN Population Division – Aging and Health Reports

Proprietary Elements:

  • CMI Data Analytics Tool, and Proprietary CMI Existing Repository of information for last 8 years

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About Author

Komal Dighe is a Management Consultant with over 8 years of experience in market research and consulting. She excels in managing and delivering high-quality insights and solutions in Health-tech Consulting reports. Her expertise encompasses conducting both primary and secondary research, effectively addressing client requirements, and excelling in market estimation and forecast. Her comprehensive approach ensures that clients receive thorough and accurate analyses, enabling them to make informed decisions and capitalize on market opportunities.

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Frequently Asked Questions

The Portable Ultrasound Bladder Scanner Market is estimated to be valued at USD 160.4 Mn in 2025, and is expected to reach USD 246.0 Mn by 2032.

The CAGR of the Portable Ultrasound Bladder Scanner Market is projected to be 6.3% from 2025 to 2032.

High prevalence of urological diseases and Increasing awareness of urological disease is expected to drive growth of market.

3D portable ultrasound bladder scanner is the leading product type segment in the market.

Prouct recall by regulatory authority  is expected to hinder the market.

Major players operating in the market include C. R. Bard, Inc. (Becton, Dickinson and Company), dBMEDx Inc., Healcerion Co., Ltd. , Verathon Inc., SRS Medical Systems Inc., Laborie Medical Technologies Inc., Lilium Otsuka Co. Ltd,  Echo Son SA, Signostics Inc., Sonostar Technologies Co., Limited, Caresono Technology Co., Ltd., ., EchoNous, Roper Technologies, Inc., canon medical systems corporation , Koninklijke Philips N.V. , Siemens Healthcare GmbH, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. ,alpinion medical systems co.,  Samsung healthcare and GE Healthcare Inc.
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