MedAI Verdict
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Artera

by Artera  ·  US

Last verified

AI risk scores from H&E slides for prostate and breast cancer, run by a CLIA lab. ArteraAI Prostate software is FDA De Novo authorized.

Visit Artera (opens in new tab)Read our methodology

At a glance

Pricing
No public price.
HIPAA
Attested
SOC 2
Type II
EHRs
—
Founded
—
HQ
US
On this page

Independent score  ·  By our public rubric

65/100Top-ranked

Editorial rating 4.5 / 5

How it’s computed →
  • Regulatory & Compliance
    28/28

    FDA cleared (2 K-numbers on record)

  • Clinical Integration
    0/6.6

    No EHR integrations listed

  • Evidence Strength
    22.5/28.8

    4 peer-reviewed papers

  • Vendor & Market
    3/18

    Seed-stage or unfunded

  • Sentiment & Transparency
    2.5/5

    Pricing on request, no public amounts

▸ Show all 11 dimensions

Regulatory & Compliance

  • FDA clearance18/18

    FDA cleared (2 K-numbers on record)

  • HIPAA / SOC2 / BAA10/10

    HIPAA + (SOC2 or BAA) attested

Clinical Integration

  • 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

Evidence Strength

  • Peer-reviewed papers15/21

    4 peer-reviewed papers

  • RCT / meta-analysis / systematic review8/8

    1 RCT/Meta-Analysis/Systematic Review

Vendor & Market

  • Funding & adoption signal3/12

    Seed-stage or unfunded

  • Years in market0/6

    Founded year not recorded

Sentiment & Transparency

  • Pricing transparency3/5

    Pricing on request, no public amounts

Scored November 2, 2026 · Public scoring method v1.2.0

AI risk scores from H&E slides for prostate and breast cancer, run by a CLIA lab. ArteraAI Prostate software is FDA De Novo authorized.

No public price. HIPAA + SOC 2 Type II attested.

Bottom line

Artera sells AI risk scores built from scanned H&E biopsy slides and clinical variables. The ArteraAI Prostate Test is delivered by Artera's CLIA lab as a lab-developed test, while the software device ArteraAI Prostate holds De Novo DEN240068 from July 2025. ArteraAI Breast holds 510(k) K254115 from May 2026, and how the breast test is sold is not stated. Prostate cancer teams are the ones with an external validation, an implementation trial and a Decipher comparison behind the score. The breast score is prognostic, so a team seeking a treatment-benefit prediction in breast cancer would not get one.

What does a clinician order?

Artera lists prostate test versions for biopsy, post-prostatectomy and metastatic hormone-sensitive disease. The vendor says the analysis uses existing H&E slides with no additional staining or preparation, and that results come within one to two days after the lab receives the specimen. The ArteraAI Breast Cancer Test, in the vendor's words, provides 5- and 10-year distant metastasis risk for early-stage breast cancer.

The homepage lists SOC 2 Type II and HIPAA compliance and shows a CAP logo.

What did FDA authorize?

DEN240068 was decided on July 31, 2025 under product code SFH and 21 CFR 864.3755, a pathology software algorithm analyzing digital images for prostate cancer prognosis. The output is a 10-year risk of distant metastasis and prostate cancer-specific mortality for males 55 or older. FDA authorized a Predetermined Change Control Plan with it, and the device uses whole-slide images from an FDA-cleared interoperable scanner. Artera says a Breakthrough Device Designation preceded the De Novo.

K254115 was decided on May 4, 2026 for early-stage HR+/HER2-negative invasive breast cancer. The score assigns a low or high distant-metastasis risk group at a predefined cutoff. The DEN240068 document and Artera's site describe the score as prognostic.

What does the published work show?

An NEJM Evidence paper (PMID 38320143) presents a predictive model for the benefit of androgen deprivation therapy. A Lancet Digital Health paper from 2025 externally validated the multimodal prognostic model in advanced prostate cancer. A BMC Cancer paper reports a multicentre implementation trial of the AI biomarker for shared decisions on androgen deprivation, and a JNCI Cancer Spectrum analysis models the cost-effectiveness of the AI model for androgen deprivation in intermediate-risk prostate cancer.

A 2026 Clinical Cancer Research paper compares Decipher and the Artera model patient by patient and has an Artera-affiliated author. Many authors across the product literature are Artera-affiliated. A 2025 JCO Clinical Cancer Informatics paper covers multimodal AI applied to baseline histopathology for distant recurrence in breast cancer.

Is the test reimbursed?

The homepage claims the test is fully reimbursed for Medicare patients and that many commercial health plans cover it. It also carries a Billing link and no public price. The vendor describes itself as "the first and only AI test to be included in the NCCN Clinical Practice Guidelines".

The verdict

A prostate cancer team that wants a prognostic score from an existing H&E biopsy slide, and accepts ordering a lab result, has the strongest published support in this product. A breast oncology team gets a May 2026 clearance whose published support includes a 2025 paper on baseline histopathology and distant recurrence, and a team that wants a treatment-benefit prediction gets a prognostic score only.

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.

TierMonthlyAnnualNotes
EnterpriseNot statedNot statedNo public price.

Source: vendor pricing page. Last checked November 2, 2026.

What deploys cleanly

Carries FDA 510(k), SOC 2 Type II, HIPAA per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.

What the literature says

4 peer-reviewed studies indexed on PubMed evaluate Artera in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.

Multi-institutional Patient-level Comparison of Decipher Genomic Classifier and Artera Multimodal Artificial Intelligence (MMAI) in Prostate Cancer. (opens in new tab)
Hong BH, Olabumuyi AA, Zhao SG, et al.· Clin Cancer Res· 2026
The Decipher Prostate Genomic Classifier (GC) and ArteraAI Multimodal Artificial Intelligence (MMAI) platform are widely used prognostic tools for localized prostate cancer (PCa), yet no direct comparison has been performed within the same patient cohort. We sought to evaluate the concordance and prognostic value of GC and MMAI across multi-institutional cohorts totaling 688 patients with localized and oligometastatic PCa. These included populations enriched for African American and East Asian patients. GC and MMAI scores were stratified into risk groups based on specimen type (biopsy or radi…
External validation of a digital pathology-based multimodal artificial intelligence-derived prognostic model in patients with advanced prostate cancer starting long-term androgen deprivation therapy: a post-hoc ancillary biomarker study of four phase 3 randomised controlled trials of the STAMPEDE platform protocol. (opens in new tab)
Parker CTA, Mendes L, Liu VYT, et al.· Lancet Digit Health· 2025RCT
Effective prognostication improves selection of patients with prostate cancer for treatment combinations. We aimed to evaluate whether a previously developed multimodal artificial intelligence (MMAI) algorithm was prognostic in very advanced prostate cancer using data from four phase 3 trials of the STAMPEDE platform protocol. We included patients starting androgen-deprivation therapy in the docetaxel, docetaxel plus zoledronic acid, abiraterone, or abiraterone plus enzalutamide trials. Patients were recruited at 112 sites. We combined all standard-of-care control patients (including those al…
A multicentre implementation trial of an Artificial Intelligence-driven biomarker to inform Shared decisions for androgen deprivation therapy in men undergoing prostate radiotherapy: the ASTuTE protocol. (opens in new tab)
Wegener E, Ng M, Guerrieri M, et al.· BMC Cancer· 2025
Androgen deprivation therapy (ADT) improves outcomes in men undergoing definitive radiotherapy for prostate cancer but carries significant toxicities. Clinical parameters alone are insufficient to accurately identify patients who will derive the most benefit, highlighting the need for improved patient selection tools to minimize unnecessary exposure to ADT's side effects while ensuring optimal oncological outcomes. The ArteraAI Prostate Test, incorporating a multimodal artificial intelligence (MMAI)-driven digital histopathology-based biomarker, offers prognostic and predictive information to…
Multimodal Artificial Intelligence Model From Baseline Histopathology Adds Prognostic Information for Distant Recurrence Assessment in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer. (opens in new tab)
Kates-Harbeck D, Kreipe H, Gluz O, et al.· JCO Clin Cancer Inform· 2025
Prognostic assessment in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (EBC) remains challenging, given relatively low rates of disease progression. Modern artificial intelligence (AI)-based techniques have provided advanced prognostic tools in cancer. The Artera multimodal AI (MMAI) platform, using digital histopathology and clinical data, was applied to develop and test a prognostic risk assessment algorithm in HR+/HER2- EBC. Hematoxylin and eosin (H&E) slides from pretreatment breast biopsy and surgical specimens were digitize…

See all on PubMed (opens in new tab)

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