Artera

Artera is a global leader in precision medicine, leveraging multimodal artificial intelligence (MMAI) to personalize cancer care. Artera's MMAI platform leverages a patient's digitized histopathology images along with the patient's clinical data to determine cancer aggressiveness and predict therapy benefit. This approach has been validated in multiple Phase 3 randomized trials across different cancers and is available in multiple versions across the globe.

Artera's FDA-authorized software products include ArteraAI Prostate (de novo authorization) and ArteraAI Breast (510(k) clearance). In addition, Artera has received CE Marking for its prostate and breast cancer in vitro diagnostic tests, supporting regulated availability in international markets.

Applications by this vendor

ArteraAI Breast

FDA | H&E

ArteraAI Breast provides 5- and 10-year risks of distant metastasis and ArteraAI risk score for HR+/HER2-, N0 or N1, early stage invasive breast cancer patients, to assist physicians with prognostic risk-based decisions with other clinical factors.

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