AI cancer detection software Aiosyn gets European certification
The software helps saving time, boost productivity, and improve diagnostics consistency.
Published on January 10, 2025
Aiosyn Mitosis Breast, an AI-driven software for breast cancer detection, received the CE mark certification—the European conformity certification for products. This milestone marks a significant advancement in pathology, enhancing diagnostic accuracy and efficiency. The algorithm, validated in a multi-center clinical study, delivers up to 60% time savings per slide and boosts productivity by 15%. With the potential to improve diagnostic consistency by 32.6%, over 90% of clinical study participants are keen to integrate this tool into their workflows.
Aiosyn achieved this certification under the In Vitro Diagnostic Regulation (IVDR). The certification applies explicitly to their mitotic figure counting algorithm, making it the first IVDR-certified application for mitosis counting in breast cancer diagnostics. As Wouter Bulten, Chief Operating and Product Officer at Aiosyn, highlighted, "CE-IVDR certification is setting a new benchmark for quality and safety in medical devices, including those powered by AI."
This certification arrives at a crucial time in breast cancer diagnostics. With 2.3 million new breast cancer cases diagnosed annually worldwide, including 604,900 cases in the WHO Europe region in 2022, the need for precise diagnostic tools is paramount. The disease remains the most common cancer among women in 157 out of 185 countries, affecting approximately 1 in 12 women in countries with very high Human Development Index.
Future impact and integration
Patrick de Boer, CEO of Aiosyn, emphasizes their commitment to partnering with pathology laboratories to demonstrate the software's value in breast cancer grading. The high interest from clinical study participants, with over 90% expressing eagerness to incorporate the algorithm into their daily workflow, suggests a promising future for AI-assisted pathology. This advancement aligns with broader healthcare goals, potentially contributing to improved breast cancer detection and treatment outcomes.
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