- No public price.
- Not disclosed
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- NL
Pathology
Aiosyn
by Aiosyn · NL
AI tissue slide QC and breast mitosis counting for pathology labs. Aiosyn Mitosis Breast carries an IVDR CE mark.
On this page
6/100
Not rated: too little independent evidence yet.
- Regulatory & Compliance0/28
No FDA clearance listed
- Clinical Integration0/6.6
No EHR integrations listed
- Evidence Strength0/28.8
No peer-reviewed coverage
- Vendor & Market3/18
Seed-stage or unfunded
- Sentiment & Transparency2.5/5
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance0/18
No FDA clearance listed
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- EHR integrations (count)0/4
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/2
None of the top-3 EHRs covered
- Peer-reviewed papers0/21
No peer-reviewed coverage
- RCT / meta-analysis / systematic review0/8
No RCT, meta-analysis, or systematic review
- Funding & adoption signal3/12
Seed-stage or unfunded
- Years in market0/6
Founded year not recorded
- Pricing transparency3/5
Pricing on request, no public amounts
AI tissue slide QC and breast mitosis counting for pathology labs. Aiosyn Mitosis Breast carries an IVDR CE mark.
No public price.
Evidence record
No FDA decision cited in our research as of November 2, 2026.
- Score computed November 2, 2026, method 1.2.0
- Review written November 2, 2026
MedAI Verdict, Aiosyn record, https://medaiverdict.com/tools/aiosyn, version November 2, 2026
Bottom line
Aiosyn, a Radboudumc spin-off in Nijmegen, sells AI image analysis for digital pathology. AiosynQC covers slide quality control, Aiosyn Mitosis Breast counts mitoses in breast cancer assessment, and NephroPath classifies kidney structures in preclinical studies. The vendor announced on January 7, 2025 that Mitosis Breast achieved CE certification under IVDR. No FDA clearance for any Aiosyn product is known. A European lab weighing a mitosis-counting aid is the clinical buyer in view, and a pharma team running kidney studies is the research buyer. A US lab needing an FDA-listed product has no known Aiosyn option.
Which Aiosyn product has a regulatory mark?
The vendor's January 7, 2025 headline calls Mitosis Breast the first AI-powered mitosis detection solution to achieve CE mark certification under IVDR. A second headline, dated June 26, 2025, says Aiosyn and Telemis advance breast cancer diagnosis with IVDR-certified AI technology. Third-party summaries tie the mark to Mitosis Breast and not to AiosynQC. The certificate scope and the notified body are not verified.
The homepage shows an ISO 13485 badge from BSI.
What do AiosynQC and NephroPath do?
AiosynQC checks digitized H&E and IHC slides for out-of-focus regions, tissue folds, incomplete scans and white-balance errors. The news page lists AiosynQC Pulse external assessments (November 2024), white balance checks (February 2025) and incomplete scan detection (April 2025). A Radboudumc case study of AiosynQC, dated December 19, 2024, is vendor-run.
NephroPath classifies glomeruli, tubules and arteries and sits on the research side. The vendor also lists AI read-outs for atherosclerosis, brain and liver studies, and GlomeruCount has been offered on the Sectra Amplifier Marketplace since September 18, 2024. Custom AI development is offered on both the clinical and the biopharma side.
How does the software reach a lab?
The vendor says it delivers through the scanner and platform vendors laboratories already use. It names Argos Scanner, Sectra Amplifier, Pramana, Pathomation and Telemis. The homepage lists Radboud university medical center, Amsterdam UMC, Leiden University Medical Center, Physiogenex and HistoWiz as customers and partners.
A EUR 2.4M round closed on September 9, 2025 with TNO Ventures, Oost NL, LUMO Labs and Health Innovations, alongside a strategic partnership with TNO. Aiosyn sells by enterprise quote and shows no figure.
What has been published?
One PubMed paper carries the Aiosyn name: a 2026 study in the European Journal of Pharmaceutical Sciences (PMID 42309325) that applied quantitative image analysis to dapagliflozin in a diabetic nephropathy rat model. That is preclinical NephroPath use and not a clinical validation. A peer-reviewed validation of Mitosis Breast or AiosynQC was not identified under the product names.
The verdict
The split is by region and by use. A European pathology lab can weigh Mitosis Breast, which the vendor announced as IVDR-certified with the certificate scope unverified, and AiosynQC, whose own regulatory status is unconfirmed. A pharma team with preclinical kidney studies is NephroPath's market. A US lab that needs FDA-listed software has no known Aiosyn product, and a buyer who wants peer-reviewed clinical validation first has a rat study as the only PubMed paper carrying the Aiosyn name.
Editorial review last generated November 2, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | Not stated | Not stated | No public price. |
Source: vendor pricing page. Last checked November 2, 2026.
What deploys cleanly
Carries CE, ISO 13485 (vendor badge, homepage) per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
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