ArteraAI Prostate

FDA | Prostate | Amplifier Integrator | H&E

Description of use

ArteraAI Prostate is a software only device intended to analyze scanned histopathology whole slide images (WSIs) from treatment-naïve prostate core needle biopsies stained using Hematoxylin & Eosin (H&E) stains.
It provides 10-year risks of distant metastasis and prostate cancer specific mortality and is intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors in non-metastatic prostate cancer patients.

It is intended for males 55 years of age or older without clinically or pathologically defined metastases, and who are candidates for curative intent management.

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

The application content is provided by the respective AI vendors.