Bot Image’s ProstatID® Achieves UKCA Certification for AI-Assisted Prostate MRI

UKCA certification adds to ProstatID’s existing FDA clearance and European CE marking, supporting Bot Image’s international regulatory strategy and its commitment to AI-assisted prostate imaging.

Bot Image, Inc. has achieved UKCA certification for ProstatID®, its artificial intelligence (AI) software designed to assist radiologists in detecting and characterizing suspicious lesions on prostate MRI.

The certification, effective October 31, 2025, was granted under the UK Medical Devices Regulations 2002 and covers image analysis software for the detection of prostate lesions. It represents an important milestone in Bot Image’s international regulatory strategy and provides an additional conformity assessment pathway for healthcare organizations in Great Britain evaluating AI-assisted prostate imaging technology.

With UKCA certification, European CE marking, and U.S. Food and Drug Administration (FDA) 510(k) clearance, ProstatID holds regulatory credentials across three major healthcare markets.

Supporting Radiologists with AI-Assisted Prostate MRI Analysis

Prostate MRI plays an increasingly important role in evaluating patients with suspected prostate cancer, helping clinicians identify suspicious regions and determine whether further investigation, including biopsy, may be appropriate.

Interpreting prostate MRI requires specialized expertise. Radiologists must evaluate multiple imaging sequences, assess potentially subtle abnormalities, and determine the likelihood of clinically significant cancer.

ProstatID is designed to support this process by providing an additional, AI-generated analysis of prostate MRI images.

Using T2-weighted (T2W), diffusion-weighted (DWI), and apparent diffusion coefficient (ADC) imaging, the software analyzes prostate anatomy and identifies regions suspicious for cancer.

Its outputs include:

• Suspicious lesion identification: Colorized overlays highlighting regions that warrant closer radiologist review.
• PI-RADS & Gleason grade assessment support: 100-point score aligned with PI-RADS and calibrated to Gleason grades to assist with characterization of suspicious findings.
• Three-dimensional reconstruction & visualization: 3D renderings of prostate anatomy and identified regions of interest. Compatible with most FUSION guidance systems.
• Prostate volume measurements: Quantitative information that can contribute to clinical assessment.
• Structured reporting: A PDF report and additional DICOM imaging series containing AI-generated findings.

ProstatID is intended for use as a concurrent reading aid. Radiologists review its findings alongside the original MRI images and other available clinical information, retaining responsibility for the final interpretation.

By presenting suspicious regions and quantitative information in an accessible visual format, ProstatID provides another source of information for clinicians evaluating prostate MRI examinations.

A Milestone in International Regulatory Recognition

UKCA certification adds to ProstatID’s regulatory credentials in the United States and European Union.

United States — FDA 510(k) clearance

ProstatID received FDA clearance under 510(k) K212783 on July 8, 2022. Its cleared indications describe computer-assisted detection and diagnosis (CADe/CADx) software intended to support physicians interpreting prostate MRI examinations.

European Union — CE marking

In October 2025, Bot Image announced CE certification for ProstatID under the European Union Medical Device Regulation (EU) 2017/745.

Great Britain — UKCA certification

ProstatID’s UKCA certification became effective October 31, 2025, under the UK Medical Devices Regulations 2002. Its stated scope covers image analysis software for the detection of prostate lesions.

UKCA marking provides a domestic conformity assessment route for medical devices placed on the market in Great Britain, including England, Scotland, and Wales.

The UK government has also announced plans for the indefinite recognition of qualifying CE-marked medical devices in Great Britain, alongside the continuing UKCA route.

Each regulatory framework has distinct requirements and intended-use provisions. Together, these credentials reflect Bot Image’s efforts to support the evaluation and adoption of ProstatID across international healthcare markets.

Why AI-Assisted Prostate MRI Matters in the UK

Prostate MRI is an established component of the UK’s diagnostic pathway for suspected prostate cancer.

The National Institute for Health and Care Excellence (NICE) guideline NG131 recommends multiparametric MRI (mpMRI) as the first-line investigation for patients with suspected clinically localized prostate cancer, with findings reported using a five-point Likert scale.

As prostate MRI remains central to diagnostic decision-making, imaging departments need reliable processes for reviewing complex examinations and communicating findings to referring clinicians.

AI-assisted software such as ProstatID offers an additional tool for radiologists, providing visual analysis and structured information that can be considered alongside the conventional interpretation.

There is also growing clinical interest in biparametric MRI (bpMRI), which uses T2-weighted and diffusion-weighted imaging without requiring a dynamic contrast-enhanced sequence.

The international PRIME trial, published in JAMA in 2025, found that bpMRI was noninferior to mpMRI for detecting clinically significant prostate cancer in the studied population when adequate image quality was maintained.

Although the PRIME trial did not evaluate ProstatID, it contributes to the broader discussion about prostate MRI protocols and the role of non-contrast imaging.

ProstatID analyzes T2-weighted, diffusion-weighted, and ADC images without using dynamic contrast-enhanced images in its AI analysis. When contrast-enhanced sequences are available, radiologists should consider them as part of their complete interpretation.

Because NICE currently recommends Likert reporting, UK imaging providers evaluating ProstatID should also consider how its suggested PI-RADS scores would be incorporated into their existing reporting workflows.

Designed for Integration into Clinical Imaging Workflows

For radiology departments and imaging providers, adopting new technology requires careful consideration of clinical workflow and integration with existing systems.

ProstatID is designed to work with medical imaging studies in the DICOM format through a Picture Archiving and Communication System (PACS).

MRI examinations can be transmitted to ProstatID for analysis, with resulting images and reports returned to the patient study for radiologist review.

This approach allows AI-generated information to be considered within the broader imaging workflow while maintaining the radiologist’s role in reviewing findings and making the final interpretation.

Healthcare organizations considering ProstatID should evaluate its technical integration, intended use, information governance requirements, and compatibility with local clinical reporting practices.

Looking Ahead: Prostate MRI AI in Great Britain

Bot Image’s UKCA certification represents another step in the company’s international regulatory development and its efforts to bring AI-assisted prostate MRI analysis to healthcare providers across multiple markets.

For radiology departments, imaging centers, urology practices, and healthcare technology partners in Great Britain, the milestone provides an opportunity to explore ProstatID’s capabilities and evaluate how AI-assisted analysis could complement existing prostate MRI interpretation workflows.

Bot Image welcomes inquiries from healthcare organizations and distribution partners interested in learning more about ProstatID, its technical requirements, and opportunities for clinical evaluation.

Contact Bot Image to discuss ProstatID or explore its potential role in your organization.

For more information about the clinical research supporting ProstatID, visit the Bot Image publications page.

Frequently Asked Questions

What does UKCA certification mean for ProstatID?

UKCA certification indicates that ProstatID has undergone a conformity assessment under the UK Medical Devices Regulations 2002. The certificate covers image analysis software for the detection of prostate lesions and applies to the Great Britain regulatory framework.

Is ProstatID also FDA-cleared and CE-marked?

Yes. ProstatID received FDA 510(k) clearance in July 2022 and obtained CE certification under the European Union Medical Device Regulation in October 2025. Each regulatory credential has its own requirements and intended-use scope.

Does ProstatID replace a radiologist?

No. ProstatID is a concurrent reading aid. The reporting radiologist remains responsible for interpreting the MRI examination and incorporating relevant clinical information into patient management decisions.

Can ProstatID analyze prostate MRI without contrast?

ProstatID analyzes T2-weighted, diffusion-weighted, and ADC images, which are included in biparametric MRI examinations. Dynamic contrast-enhanced images are not part of its AI analysis, although radiologists should review them when available.

References

1. 1. UK Medicines and Healthcare products Regulatory Agency: UK Approved Bodies for Medical Devices
   2. FDA: ProstatID 510(k) K212783
   3. NICE NG131: Prostate Cancer Diagnosis and Management
   4. JAMA: Biparametric vs Multiparametric MRI for Prostate Cancer Diagnosis — PRIME Trial
   5. UK Government: Indefinite Recognition of CE-Marked Medical Devices
   6. Bot Image: CE Mark Certification Announcement