Cancer · Prediction and risk
ArteraAI Prostate: AI that reads biopsy slides to forecast prostate cancer outcomes
On 31 July 2025 the US FDA granted Artera's De Novo request for ArteraAI Prostate, software that analyses digitised biopsy slides to estimate long-term outcomes for men with non-metastatic prostate cancer. It's authorised in the US only and supports, rather than replaces, treatment decisions.
How far away is this?
FDA 'granted' a De Novo request, which authorises marketing in the US. Note the word: granted, not 'approved'. The rating applies to the US only and reflects authorisation; we haven't confirmed how widely it is used with patients.
Where is it approved?
| Region | Regulator | Status | Notes |
|---|---|---|---|
| United States | FDA | FDA De Novo granted, 31 July 2025 (DEN240068, prescription use).[1] | |
| European Union | CE mark / EMA | CE marked (regulator record not verified) | Artera says the ArteraAI Prostate Biopsy Assay (its EU product, distinct from the US 'ArteraAI Prostate' software) received CE marking under the EU IVDR on 21 April 2026. Company claim: the press release does not name the notified body, and we couldn't find a EUDAMED record.[5] |
| United Kingdom | MHRA | Unknown (UKCA company-reported, not verified) | Artera's April 2026 press release lists the Prostate Biopsy Assay as 'UKCA and CE-marked'. We couldn't confirm this on the MHRA device register (PARD).[5] |
| Australia | TGA | Unknown | We couldn't search the ARTG on 16 Oct 2026 because the TGA site returned an error. We haven't seen any claim of TGA inclusion.[6] |
Authorised in the US (FDA record). Artera says its EU/UK product is CE and UKCA marked, but we haven't confirmed that on regulator registers. Australia is unknown. "Unknown" means we haven't verified it, not that it's unavailable. Approval in one country isn't approval in another.
What is it?
After a prostate biopsy, the tissue slide is scanned. The software looks at the image alongside clinical details and gives a risk estimate that can help a man and his doctors weigh up treatment options.
What's the evidence?
FDA granted the De Novo request for ArteraAI Prostate (DEN240068) on 31 July 2025, creating a new Class II device type: software analysing digital pathology images for cancer prognosis.[1]
Evidence stage: Approved & in use · #c1
It's a prescription device for men aged 55 or over whose prostate cancer hasn't spread. FDA's decision summary says results are unlikely to be the only factor in clinical decisions and may support risk-based decisions within recommended guidelines.[3]
Evidence stage: Approved & in use · #c2
FDA's decision summary says the AI was trained on biopsy slide images from several past randomised trials and other studies, using what actually happened to those patients. Its clinical validation study included 886 patients from three US sites: men it put in the high-risk group had a 28.1% 10-year risk of cancer spreading (distant metastasis), versus 3.3% in the low-risk group and 8.1% overall. It is a risk estimate built from historical data, and it was developed by the company that sells it.[3]
Evidence stage: Approved & in use · #c3
FDA notes that only 72 African American patients were in the analysis, so the estimates for them are less certain. The authorisation also includes a plan that lets the company add other approved slide scanners without a new submission.[3]
Evidence stage: Approved & in use · #c4
What does it mean for me?
If you're in the US with prostate cancer that hasn't spread, you can ask your specialist whether a test like this is relevant to you. It gives a risk estimate. It doesn't decide treatment, and active surveillance, surgery and radiotherapy decisions still rest on the full picture. Outside the US, Artera says a version is CE marked in the EU and UKCA marked in the UK, but we haven't confirmed that with regulators.
What could I ask my doctor?
- Would an AI-based risk test change my treatment options?
- Is this test available here, and is it covered?
- How does its estimate compare with my current risk group?
These are general starting points, not a recommendation to choose any particular test or treatment.
If you're worried about your health right now, contact your doctor or local health advice line. In an emergency, contact your local emergency number.
Change history
- : First published.
- : Updated after independent fact-check and clinical review
- : Approvals updated: EU CE mark (IVDR, Apr 2026) and UKCA added as company-reported, not yet verified on EUDAMED or MHRA PARD; TGA/ARTG still unknown.
- : Review label corrected: this page was not clinically reviewed. Earlier labels saying 'independent fact-check' and 'clinical review' were wrong; checks so far were AI-assisted source checks only.
General information only, not medical advice. Talk to your doctor about your situation. AI-assisted source check. Not clinically reviewed.
References
- FDA De Novo database: DEN240068. accessdata.fda.gov. Regulator. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240068
- FDA De Novo grant letter (PDF). accessdata.fda.gov. Regulator. https://www.accessdata.fda.gov/cdrh_docs/pdf24/DEN240068.pdf
- FDA decision summary (PDF). accessdata.fda.gov. Regulator. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN240068.pdf
- Artera press release. artera.ai. Press release (claim). https://artera.ai/news/artera-receives-u-s-fda-de-novo-marketing-authorization-for-ai-digital-pathology-software-revolutionizing-prostate-cancer-care
- Artera press release: CE marking (21 Apr 2026). artera.ai (2026). Press release (claim). https://artera.ai/news/artera-secures-ce-marking-for-its-ai-prostate-and-breast-cancer-assays-unlocking-global-expansion
- TGA record or statement: Australia. tga.gov.au. Regulatory or manufacturer record. https://www.tga.gov.au/resources/artg
Publisher shown as the website hosting each source. Dates are given where the source label includes them.