Certification opens the European market for the first FDA-cleared AI platform for prostate MRI interpretation.
OMAHA, Neb., Oct. 27, 2025 /PRNewswire/ — Bot Image, Inc., a leader in AI-powered diagnostic imaging, today announced that its flagship software, ProstatID®, has achieved CE certification under the European Union’s Medical Device Regulation (EU) 2017/745, marking a major milestone in the company’s global expansion.
The certification, issued by Intertek Medical Notified Body AB (NB 2862) under Annex IX, Chapters I & III, confirms that Bot Image’s Quality Management System and product design comply with all applicable EU safety and performance requirements.
Certificate No.: 28620225053
Effective Date: 10 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 clearance already in place, ProstatID® is now positioned to reach healthcare systems across Europe, where consistent, high-accuracy prostate MRI interpretation is urgently needed.”
ProstatID® uses advanced artificial intelligence to automatically identify, quantify, and classify prostate lesions from MRI scans, improving diagnostic confidence and reducing variability between radiologists. The platform complements routine clinical workflows and supports biopsy decision-making through standardized lesion mapping and probability scoring.
Furthermore, this clearance also validates the utility of the software for use in the Active Surveillance community as it creates a colorized record of lesions detected and their changes of size and risk stratification over time.
“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 partners can now implement ProstatID® with full confidence that it meets the most demanding regulatory standards worldwide.”
Bot Image will immediately begin onboarding European 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-certified AI software for prostate MRI interpretation, enabling earlier, more confident detection of clinically significant prostate cancer.
For more information please contact: Melanie Jones at mjones@botimageai.com
SOURCE Bot Image Inc.
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