ArteraAI Breast

FDA | Breast | Amplifier Integrator | H&E

Amplifier Marketplace Pathology

Description of use

ArteraAI Breast is a software only device intended to analyze physician-provided clinical variables and scanned histopathology whole slide image (WSI) from treatment-naïve breast resection specimens prepared from formalin fixed paraffin-embedded (FFPE) tissue and stained using Hematoxylin & Eosin (H&E) stains. ArteraAI Breast provides 5- and 10-year risks of distant metastasis and ArteraAI risk score for patients with HR+/HER2-, N0 or N1, early stage invasive breast cancer and is intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors.

ArteraAI Breast is intended to utilize WSIs acquired from an FDA-cleared interoperable scanner with which ArteraAI Breast has been authorized for use.

How is the application integrated?

• Application can be launched from Sectra's pathology image window: Yes
• Results will be shown in Sectra's pathology image window: Yes

Ask your Sectra representative which version of the Sectra PACS is compatible with the highlighted integration standards.

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Referring articles

The below are peer-reviewed articles that have been submitted by the AI vendor to serve as scientific validation of the application.

Other applications by this vendor

ArteraAI Prostate
FDA | H&E
ArteraAI Prostate is a software only device intended to analyze scanned histopathology whole slide images from treatment-naïve prostate core needle biopsies. It provides 10-year risks of distant metastasis and prostate cancer specific mortality.
ArteraAI Breast Cancer Assay
CE | H&E
IVDR Intended Purpose: The ArteraAI Breast Cancer Assay is an in vitro diagnostic medical device software device based on artificial intelligence (AI) that assesses physician-provided clinical variables and whole slide images (WSI) of Breast Resection specimens to provide risk estimates of Distant Metastasis for patients with HR+/ HER2- breast cancer. It is intended to assist clinicians with risk-based decisions in patients with HR+/HER2-, N0 or N1, early stage invasive breast cancer.
ArteraAI Prostate Biopsy Assay
CE | H&E
ArteraAI Prostate Biopsy Assay is an IVD software based on AI that assesses clinical variables and H&E stained WSIs of prostate biopsies to provide risk estimates of disease prognosis and prediction of risk appropriate treatment benefit

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The application content is provided by the respective AI vendors.