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Aiosyn

by Aiosyn

AI Application
Low Confidence

Aiosyn makes AI software for digital pathology laboratories; its clinical products are AiosynQC and Aiosyn Mitosis Breast, and it also does image analysis for biopharma research. The vendor says AiosynQC checks every scanned whole-slide image as it arrives, segments out-of-focus areas, tissue folds, air bubbles, pen marks, dust, ink, white-balance problems and incomplete scans on H&E and IHC slides, and sorts slides into accepted, needing a new preparation or needing a rescan, with sensitivity set per laboratory; lab technicians act on the flags before slides reach the pathologist. Aiosyn Mitosis Breast uses deep learning to mark mitotic figures across a breast-cancer slide, and the pathologist confirms the count. The vendor says AiosynQC is not a medical device under the IVDR and now labels Mitosis Breast research use only, although it announced IVDR CE marking for it in January 2025. Both run on-premise or in the cloud, through Sectra Amplifier, Techcyte Fusion or a direct link to the image management system.

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Transparency Score

Weighted across four pillars · updated October 20, 2026

Overall grade
35% weighted
ABCDF
Model
—
Not yet assessed
Infrastructure
—
Not yet assessed

Capabilities

Slide Quality Control
Artifact Segmentation
Rescan Flagging
Mitotic Figure Detection

Vendor Information

Complete information about the vendor/provider of this AI application

AiosynView all products →
Aiosyn B.V.(Trading as: Aiosyn)
Contact Information
www.aiosyn.com/
contact@aiosyn.com
Registered Address
Toernooiveld 300, Nijmegen, Gelderland, 6525 EC, NL

EU AI Act Provider Information

Verification Status:
Verified
(Last verified: October 20, 2026)
Aiosyn B.V.(Trading as: Aiosyn)
Toernooiveld 300, Nijmegen, Gelderland, 6525 EC, NL
contact@aiosyn.com
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.
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Added: September 9, 2026
Updated: October 20, 2026

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