Certification opens the United Kingdom market for the first FDA-cleared AI platform for prostate MRI interpretation.
OMAHA, Neb., Nov. 18, 2025 /PRNewswire/ — Bot Image, Inc., a leader in AI-powered diagnostic imaging, today announced that its flagship software, ProstatID®, has achieved UKCA certification under the European Union’s Medical Device Regulation (EU) 2017/745, marking yet another major milestone in the company’s global expansion.
The certification, issued by Intertek Medical Notified Body AB (NB 2862) under Part II MDR 2002, Annex II, confirms that Bot Image’s Quality Management System and product design comply with all applicable UKCA safety and performance requirements.
Certificate No.: 85320228106
Effective Date: 31 October 2025
Expiry: 20 September 2029
Scope: Image analysis software for the detection of prostate lesions
“This CE certification represents a pivotal step in our mission to make early, accurate prostate cancer detection accessible to clinicians and patients worldwide,” said Mike “Bing” Crosby, Chief Commercial Officer at Bot Image, Inc. “With FDA and EU clearance already in place, ProstatID® is now positioned to reach healthcare systems across the EU, UK and other countries accepting any of these certifications, where consistent, high-accuracy prostate MRI interpretation is urgently needed.”
ProstatID® uses advanced artificial intelligence to automatically detect, segment, and classify prostate lesions from MRI scans, as well as couple its digital output to an increasing number of FUSION Guidance and Treatment Systems; thus, improving not only diagnostic confidence and but serving as a Bridge between radiologists and interventionalists. The platform complements routine clinical workflows and supports biopsy decision-making through standardized lesion mapping and probability scoring; thus, creating a 3D Prostate Cancer Estimation Map .
“Achieving CE Mark under the new MDR framework underscores Bot Image’s commitment to quality, regulatory rigor, and patient safety,” said Dr. Randall W. Jones, CEO of Bot Image, Inc. “Our European and UK partners can now implement ProstatID® with full confidence that it meets the most demanding regulatory standards worldwide.”
Bot Image will immediately begin onboarding European, UK and other regional distributors and clinical partners to accelerate deployment across hospitals and diagnostic centers.
About Bot Image, Inc.
Bot Image, Inc. (www.botimageai.com) develops advanced AI-driven diagnostic imaging solutions that enhance radiologic accuracy and standardization. Its flagship product, ProstatID®, is the first FDA-cleared and CE, and UK -certified AI software for prostate MRI interpretation, and lesion classification enabling earlier, more confident detection and treatment guidance of clinically significant prostate cancer.
Media Contact:
Melanie Jones
mjones@botimageai.com
SOURCE Bot Image Inc.
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