#United Kingdom #Omaha #ProstatID #Bot Image #AI Prostate Software

Bot Image, Inc. Gains UKCA Certification for ProstatID® AI Software

In an exciting advancement for prostate cancer detection technology, Bot Image, Inc., a pioneer in AI-driven diagnostic imaging, has announced the achievement of UKCA certification for its flagship software, ProstatID®. This certification, aligned with the EU Medical Device Regulation 2017/745, is a significant leap forward in making early prostate cancer detection more accessible for medical professionals and patients alike.

The certification, granted by Intertek Medical Notified Body AB (NB 2862), assures that Bot Image's Quality Management System and the design of the ProstatID® software fulfill all essential UKCA safety and performance obligations. The certificate, numbered 85320228106, is effective from October 31, 2025, until September 20, 2029, and covers the image analysis software designed specifically for identifying prostate lesions.

Mike "Bing" Crosby, the Chief Commercial Officer of Bot Image, expressed enthusiasm about this achievement, emphasizing that it represents a pivotal move toward ensuring clinicians and patients around the globe can rely on accurate prostate cancer detection early on. With prior FDA and EU clearances already established, Bot Image is uniquely positioned to introduce ProstatID® to healthcare systems throughout the EU, UK, and other markets that acknowledge these certifications.

ProstatID® employs state-of-the-art artificial intelligence technology to automatically identify, segment, and categorize prostate lesions present in MRI scans. Moreover, it integrates its digital outcomes with a growing variety of FUSION Guidance and Treatment Systems, thereby not only enhancing diagnostic accuracy but also creating a seamless connection between radiologists and interventionalists. This innovative platform significantly complements standard clinical workflows and aids in crucial decision-making for biopsies through structured lesion mapping and probability scoring, resulting in a comprehensive 3D Prostate Cancer Estimation Map.

Furthermore, Dr. Randall W. Jones, the CEO of Bot Image, highlighted that obtaining the CE Mark under the latest MDR framework underscores their unwavering commitment to quality and regulatory standards, as well as prioritizing patient safety. With this new certification, European and UK partners can deploy ProstatID® confidently, knowing it meets the most stringent regulatory criteria worldwide.

As part of its plan to enhance accessibility to this cutting-edge technology, Bot Image will start onboarding distributors and clinical associates across Europe, the UK, and other regions. The effective deployment of ProstatID® in hospitals and diagnostic centers is anticipated to take place promptly.

About Bot Image, Inc.

Bot Image, Inc. is at the forefront of developing advanced AI-driven diagnostic imaging solutions that elevate the standards of radiologic accuracy and standardization. ProstatID® stands out as the first AI software for prostate MRI interpretation, having received both FDA clearance and CE, as well as UK certification. This innovative product enables earlier detection and more reliable treatment guidance for clinically significant prostate cancer, making it a vital tool in modern oncology.

For further information, please visit Bot Image's website or contact Melanie Jones at [email protected].