Aiosyn AI-Powered Pathology Tool

Aiosyn says AiosynQC is not a medical device under the IVDR or UK MDR 2002, is not intended as an accessory to any AI or other medical device, and is research use only in the United States and other jurisdictions; it says Aiosyn Mitosis Breast is for research use only and that, unless otherwise mentioned, its applications are research use only or not medical devices (https://www.aiosyn.com/automated-quality-control/, https://www.aiosyn.com/mitotic-figure-counting/, https://www.aiosyn.com/clinical/, read 2026-10-20). In January 2025 Aiosyn announced IVDR CE marking for Mitosis Breast; class and notified body were not published and EUDAMED lists no certificate.