LensHooke X3 PRO Semen Quality Analyzer

by Bonraybio Co., Ltd.  · Based in Taiwan → — 世界精⼦檢測和光學技術領先企業。邦睿以提供完整的男性不孕不育的解決⽅案,提⾼全球⽣殖領域的醫療品質。
Laboratory Medicine Obstetrics & Gynecology Urology

Regulatory Status Disclosed

Overview

The LensHooke X3 PRO Semen Quality Analyzer, developed by Bonraybio Co., Ltd., is an automated, in-vitro diagnostic system designed for rapid and precise human semen analysis. Utilizing optical technology and artificial intelligence, the analyzer evaluates critical sperm parameters, including sperm concentration and total motility, in alignment with the World Health Organization (WHO) guidelines.

The system is built for use by fertility specialists, urologists, and andrologists in clinical laboratories and point-of-care (POC) settings. It streamlines the diagnostic workflow by replacing subjective, manual microscopic assessments with a standardized, automated process. This reduces inter-operator variability and speeds up the delivery of diagnostic results.

Key capabilities of the LensHooke X3 PRO include:

  • A built-in 5-inch touchscreen interface for direct operation and real-time monitoring.
  • High-resolution imaging and video playback functionality to visually verify sperm movement and characteristics.
  • Multiple built-in connectivity options to facilitate seamless data transfer and integration with laboratory information systems.
  • Compatibility with specialized consumables, such as test slides and quality control beads, to maintain testing accuracy and standardization.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Use Cases

  • Male infertility diagnosis and evaluation
  • Use in clinical laboratories
  • Use in point-of-care settings
  • Research purposes
  • Application in IVF clinics and andrology labs
  • Post-vasectomy sterility confirmation (with recommended manual confirmation)

What Physicians Need to Know

Supported Assay Types
The LensHooke X3 PRO Semen Quality Analyzer provides direct and calculated measurements for sperm concentration, total motility (including progressive, non-progressive, and immotility), sperm morphology (normal forms), and pH value.
QC/QA Features
The system utilizes LensHooke X QC Beads and LensHooke X QC Reticle as quality control materials to assess the accuracy and precision of sperm counting and pH test methods. These QC materials are supplied in three different levels of control, providing known target values and ranges.
Result Interpretation AI
The LensHooke X3 PRO integrates optical design and image analysis with an artificial intelligence image processing method to automate the analysis of semen quality. It uses AIOM (Artificial Intelligence Optical Microscopic) technology for interpretation. The AI analyzes sperm concentration by unit density, calculates motility by tracing sperm trajectories, and determines morphology by comparing head and tail percentages.
Instrument Interfaces
The device features multiple built-in connectivity options. It also includes a 5-inch big touch screen and a video play function.
Turnaround Time Impact
The analyzer is designed for rapid and precise assessments of sperm parameters. The built-in AIOM system can automatically generate results in approximately five minutes.
Physician Tip

The LensHooke X3 PRO Semen Quality Analyzer offers a fully automated and user-friendly approach to semen analysis, providing critical parameters such as pH, sperm concentration, motility, and morphology. While it provides comprehensive semen analysis, it's important to note that it does not offer a complete evaluation of a male's fertility status on its own. The device is intended for in-vitro diagnostic use in clinical laboratories and point-of-care settings. For optimal results, ensure proper sample liquefaction for at least 30 minutes before testing, and perform the test within 1 hour of sample collection.

The LensHooke X3 PRO Semen Quality Analyzer has multiple built-in connectivity options. While specific LIS/LIMS integration details are not explicitly provided, the presence of connectivity features suggests potential for data transfer and integration into laboratory information systems. The company also offers 'LensHooke S10 Data Consolidation Software', which may facilitate data management and integration.

Details

Category Lab & Diagnostics, OB/GYN AI
Pricing Unknown
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Laboratory Medicine, Obstetrics & Gynecology, Urology

What the Web Says

The LensHooke X3 PRO Semen Quality Analyzer, developed by Bonraybio, is an AI-powered, automated device designed for rapid and precise assessment of sperm parameters in clinical and point-of-care settings. It analyzes sperm concentration, motility (progressive, non-progressive, immotility), morphology, and pH value. The device aims to provide accurate and standardized semen analysis, assisting physicians in identifying and treating male infertility issues.

Overall: Positive

Strengths

  • AI-powered for accurate and automated analysis of sperm parameters.
  • Provides rapid results (1-2 minutes per test).
  • User-friendly with a 5-inch touch screen and video play function.
  • Measures critical semen quality parameters including pH, concentration, motility, and morphology.
  • FDA-cleared for use in clinical laboratories and point-of-care settings.
  • Shows acceptable agreement with manual microscopic evaluation.

Limitations

  • Does not provide a comprehensive evaluation of a male's fertility status.
  • Limited information available from independent tech reviewers, Reddit, G2, or Capterra.

Based on reviews from: healthaidb.com, lenshooke.com, fda.gov, nih.gov, wjmh.org, innolitics.com, grandviewresearch.com, researchgate.net, findhealthclinics.com

Last updated: 2026-10-29

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Press & Coverage

fda.gov
LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer
The FDA granted 510(k) clearance to the LensHooke X3 PRO Semen Quality Analyzer and LensHooke X3 PRO SE Semen Quality Analyzer on May 30, 2025. The X3 PRO is intended for use in healthcare professional settings, while the X3 PRO SE is for at-home self-testing, both evaluating male fertility but not providing a comprehensive fertility assessment.
2025-05
fda.report
LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer
The LensHooke X3 PRO Semen Quality Analyzer and LensHooke X3 PRO SE Semen Quality Analyzer received 510(k) clearance from the FDA on May 30, 2025.
2025-05
researchgate.net
Artificial Intelligence-Driven Semen Analysis: Transforming Semen Analysis for Male Infertility Diagnostics
A peer-reviewed article published in April 2026 highlights the LensHooke X-Series, including the FDA-cleared X1 PRO and X3 PRO, as AI-enhanced semen analysis platforms for in-lab use. The X3 PRO, cleared in 2025, offers improved speed (1–2 min/test).
2026-04
bonraybio.com
LensHooke® New Product Hands-On Course at TSRM Congress was a great success!
Bonraybio announced that a hands-on course featuring the LensHooke X3 PRO Semen Quality Analyzer and the R10 Plus Sperm DNA Fragmentation Rapid Test Kit was successfully held at the TSRM Congress in August 2024.
2024-08
lenshooke.com
Expert Webinar_EQASRM × LensHooke X12 PRO
Bonraybio and LensHooke announced an upcoming expert webinar on September 30, 2026, focusing on External Quality Assessment (EQA) for automated semen analysis, featuring the LensHooke X12 PRO.
2026-09
innolitics.com
Pathology AI Regulatory Snapshot: April 2026
An April 2026 article mentions the Bonraybio Co., Ltd. LensHooke X3 PRO Semen Quality Analyzer as one of the semen-quality analyzers that received 510(k) clearance in 2025.
2026-04
grandviewresearch.com
Global Male Infertility Diagnosis and Treatment Market Report 2026
A September 2026 report highlights the FDA's 510(k) clearance in May 2025 of the LensHooke X3 PRO Semen Quality Analyzer, an automated platform integrating optical imaging, image-analysis algorithms, and AI for assessing sperm parameters.
2026-09
medtechspectrum.com
FDA Approvals for AI-Driven Medical Devices Surge in 2025, Revolutionizing Healthcare Diagnostics
A May 2025 article notes the FDA's clearance of the LensHooke X3 PRO Semen Quality Analyzer as part of a surge in approvals for AI-driven medical devices, aiming to enhance diagnostic accuracy and speed up clinical workflows.
2025-05

Videos

Product demos, reviews, and walkthroughs for LensHooke X3 PRO Semen Quality Analyzer.

View all on YouTube

Frequently Asked Questions

The LensHooke X3 PRO Semen Quality Analyzer measures key semen parameters including sperm concentration, motility (total, progressive, and non-progressive), morphology (normal forms), and pH value. It provides a comprehensive assessment for male fertility evaluation.
The LensHooke X3 PRO utilizes AI optical microscopy and advanced imaging software to automate the analysis process, which standardizes results and minimizes human error. It captures Full-HD dynamic images for detailed examination of sperm morphology and provides a full CASA report.
The LensHooke X3 PRO Semen Quality Analyzer is designed to comply with WHO 6th Edition guidelines for semen analysis. Studies have shown strong correlation and agreement with laboratory-based manual semen analysis.
While providing a comprehensive semen analysis, the LensHooke X3 PRO Semen Quality Analyzer does not offer a complete evaluation of a male's fertility status on its own. It is an in-vitro diagnostic system intended for use in healthcare professional settings to assess male fertility.
Alternatives to the LensHooke X3 PRO include other automated semen analyzers like the LensHooke X1 PRO and X12 PRO, as well as traditional manual semen analysis methods. Computer-Assisted Semen Analysis (CASA) systems are also available.
For quality control, the LensHooke X3 PRO utilizes LensHooke X QC Beads for semen, which assess pH value and concentration, LensHooke X QC Reticle for semen, which examines concentration, and LensHooke X QC Video for semen, which evaluates motility and morphology.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-17 | First Added: 2026-04-17
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