- No public price.
- Not disclosed
- Not disclosed
- —
- 2015
- TW
Pathology
aetherAI
by aetherAI · founded 2015 · TW
FDA-cleared slide viewer for hospital pathology labs. Bone marrow and colon polyp AI modules are TFDA approved in Taiwan.
On this page
51/100
Editorial rating 3.5 / 5
- Regulatory & Compliance18/28
FDA cleared (1 K-number on record)
- Clinical Integration0/6.6
No EHR integrations listed
- Evidence Strength14.7/28.8
2 peer-reviewed papers
- Vendor & Market9/18
Founded 2015 (11 years)
- Sentiment & Transparency2.5/5
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance18/18
FDA cleared (1 K-number on record)
- 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 papers15/21
2 peer-reviewed papers
- RCT / meta-analysis / systematic review0/8
No RCT, meta-analysis, or systematic review
- Funding & adoption signal3/12
Seed-stage or unfunded
- Years in market6/6
Founded 2015 (11 years)
- Pricing transparency3/5
Pricing on request, no public amounts
FDA-cleared slide viewer for hospital pathology labs. Bone marrow and colon polyp AI modules are TFDA approved in Taiwan.
No public price.
Evidence record
510(k)K233126 (opens in new tab)May 30, 2024
aetherSlide
2 studies on PubMed: 2 other, published 2025 to 2026. Read the literature summary
- Score computed November 2, 2026, method 1.2.0
- Review written November 2, 2026
MedAI Verdict, aetherAI record, https://medaiverdict.com/tools/aetherai, version November 2, 2026
Bottom line
aetherSlide, from the Taipei company aetherAI, holds FDA 510(k) K233126 as a software-only viewer for scanned FFPE surgical pathology slides. The clearance is for primary diagnosis with the Philips Ultra Fast Scanner and the Philips PS27QHDCR monitor, and the cleared indication contains no AI claim. The vendor lists TFDA approval in Taiwan for its bone marrow and colon polyp AI modules, with no FDA clearance listed for them. A lab that scans on that Philips hardware and wants a cleared viewer matches the clearance. A lab on another scanner, or one expecting FDA-cleared AI, sits outside it.
What does K233126 allow?
FDA decided the Traditional 510(k) on May 30, 2024 under product code QKQ and 21 CFR 864.3700, "Digital Pathology Image Viewing and Management Software". Philips IntelliSite Pathology Solution is the predicate, and the 510(k) summary is the primary validation record for aetherSlide. The indication excludes frozen section, cytology and non-FFPE hematopathology specimens.
The homepage also describes a fully automated slide scanning solution developed with Techman Robot and Hamamatsu Photonics. Hamamatsu is named as a scanning partner, and the FDA clearance names only the Philips scanner.
Do the AI modules carry approvals?
aetherAI Hema classifies bone marrow smears and dates to 2020. aetherAI Endo detects colon polyps and dates to 2021. The About page lists TFDA approval for both, gives 2022 for Endo, and dates the TFDA clearance of aetherSlide to 2020. The homepage names further applications for slide quality control, cell counting and IHC staining quantification.
A third-party summary calls aetherSlide CE-marked. Whether that would fall under IVDD or IVDR is not verified.
What do the published papers show?
PubMed returns two papers that name aetherAI or aetherSlide in title or abstract. A 2026 paper in Archives of Pathology & Laboratory Medicine (PMID 42107972) evaluates the aetherAI algorithm for breast cancer lymph node metastases after neoadjuvant chemotherapy, and asks in its title whether that chemotherapy is the "Achilles' heel" of AI lymph node evaluation. A 2025 Translational Oncology paper (PMID 39489091) compares Ki-67 labeling index morphometry from aetherAI against 3DHistech, Roche and manual counting, and has an aetherAI-affiliated author.
Two more papers carry aetherAI co-authors: a 2026 Diagnostic Pathology study of two deep-learning assistance modes used by pathologists, and a 2025 International Journal of Medical Informatics study of bone marrow cell differential counting. No independent validation of aetherSlide itself was identified.
Where is aetherAI sold, and at what price?
aetherAI says it was founded on October 7, 2015. Its 2024 Series B of NT$765M was led by CDIB Capital, and it listed on Taiwan's Emerging Stock Board on November 26, 2024. By its own account, 2023 revenue exceeded NT$100M with over 40% coming from overseas. Named customers include Chang Gung Memorial Hospital, RWTH Aachen University Hospital and University Hospital Frankfurt, and the vendor dates its European entry to 2022 through Tuebingen University Hospital.
Neither the homepage nor the About page lists a price, and the company's model reads as enterprise sales.
The verdict
aetherSlide suits a lab that already runs Philips scanning hardware, reads FFPE surgical slides and wants a cleared viewer for primary diagnosis. It does not suit a lab that wants FDA-cleared AI decision support or runs another scanner brand.
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 FDA 510(k), ISO 13485, ISO 27001 per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
Who builds it
aetherAI (aetherAI) was founded in 2015 in TW, putting it 11 years into market.
What the literature says
2 peer-reviewed studies indexed on PubMed evaluate aetherAI in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.
- Artificial Intelligence in Breast Cancer Lymph Node Evaluation: Is Neoadjuvant Chemotherapy the Achilles' Heel? (opens in new tab)
- Aziz M, Sahay A, Hung IC, et al.· Arch Pathol Lab Med· 2026
- Artificial intelligence (AI) has demonstrated high accuracy in detecting lymph node (LN) metastases in treatment-naïve invasive breast cancer. However, its performance post-neoadjuvant chemotherapy (NACT) remains underexplored, where therapy-related morphologic alterations complicate assessment. To evaluate an AI algorithm (aetherAI) for detecting LN metastases in post-NACT invasive breast cancer. This retrospective study included 72 patients (58 [80.5%] post-NACT; 14 [19.5%] treatment-naïve), yielding 526 whole slide images and 1290 LNs. AI-generated LN contours were reviewed and m…
- Comparative analysis of Ki-67 labeling index morphometry using deep learning, conventional image analysis, and manual counting. (opens in new tab)
- Alam MR, Seo KJ, Yim K, et al.· Transl Oncol· 2025
- The Ki-67 labeling index is essential for predicting the prognosis of breast cancer and for diagnosing neuroendocrine and gastrointestinal stromal tumors. However, current manual counting and digital image analysis (DIA)-based methods are limited in terms of accurate estimation. This study aimed to assess and compare the capabilities of different DIA systems for Ki-67 counting using the conventional manual counting method. A total of 239 tissue microarray cores from patients with stomach cancer were immunohistochemically stained for Ki-67 and digitally scanned. For the analysis, we employed t…
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