This marks it as an inaugural AI-powered software with the ability to predict long-term results for those with non-metastatic prostate cancer.

This regulatory milestone categorises ArteraAI Prostate as a software as a medical device (SaMD) and enables the use of such AI-assisted tools in qualified pathology laboratories across the US.

The authorisation also sets a new product code for similar future digital pathology risk-stratification applications.

The FDA’s decision includes a Predetermined Change Control Plan that allows the company to widen its platform by validating compatibility with more digital pathology scanners with no need for additional 510(k) submissions.