#USA #Omaha #CE Mark #ProstatID #Bot Image

Bot Image, Inc. Achieves CE Mark Certification for ProstatID® AI Software

Bot Image, Inc., a pioneering entity in AI-driven diagnostic imaging, has recently secured the CE Mark certification for its flagship software, ProstatID®. This key certification aligns with the European Union's Medical Device Regulation (EU MDR) and represents a monumental stride in the company’s initiatives aimed at global expansion.

The CE Mark, granted by Intertek Medical Notified Body AB (NB 2862), confirms that ProstatID® adheres to the rigorous safety and performance criteria outlined by the EU. Specifically, this certification verifies that Bot Image's quality management system and product design meet all necessary regulations for medical devices within Europe. As part of this certification, the product's scope has been validated for image analysis intended for the detection of prostate lesions.

Mike "Bing" Crosby, the Chief Commercial Officer at Bot Image, remarked, "This CE certification is a critical milestone in our objective to facilitate early and precise prostate cancer detection globally. With prior FDA clearance already achieved, ProstatID® is now strategically positioned to penetrate healthcare systems across Europe, where the need for precise prostate MRI interpretation is particularly pressing."

ProstatID® employs cutting-edge artificial intelligence algorithms to autonomously recognize, quantify, and categorize prostate lesions derived from MRI scans. This technology not only boosts diagnostic confidence but also minimizes variability in interpretations among radiologists, making it a significant enhancement in clinical workflows. Moreover, ProstatID® aids in biopsy decision-making through uniform lesion mapping and probability scoring, facilitating better-informed clinical decisions.

The significance of this software extends into the Active Surveillance community through its capability to provide a detailed colorized record of detected lesions, illustrating their size changes and associated risk levels over time. This functionality is poised to enhance monitoring within this patient population.

Dr. Randall W. Jones, CEO of Bot Image, stated, "Obtaining the CE Mark under the updated MDR framework emphasizes our dedication to high-quality products, rigorous regulatory compliance, and patient safety. Our partners across Europe can now adopt ProstatID® with the assurance that it adheres to the most stringent regulatory standards worldwide."

In response to this certification, Bot Image plans to commence onboarding European distributors and clinical partners promptly, thereby accelerating the adoption of ProstatID® throughout hospitals and diagnostic facilities.

About Bot Image, Inc.

Bot Image, Inc. specializes in the development of advanced AI-driven diagnostic imaging technologies that optimize radiological accuracy and uniformity. ProstatID® stands out as the first AI software for prostate MRI interpretation to receive FDA clearance and CE certification, enabling earlier and more confident identification of clinically significant prostate cancers. For more details, interested parties can reach out to Melanie Jones via email at [email protected].