Indica Labs HALO AI vs Tempus Digital Pathology

Tempus offers an FDA-authorized prostate algorithm and a cleared viewer from one vendor. Paige Prostate Detect holds De Novo DEN200080 from September 2021, and FullFocus holds 510(k) K241273 from January 2025. Indica's cleared product is HALO AP Dx, a case-management viewer with two 510(k)s, and its prostate AI is CE-IVD marked with no US submission known. A US cancer center that wants viewer and prostate algorithm under one contract takes Tempus. Indica goes to a pharma or translational group running quantitative analysis on brightfield and fluorescence slides with classifiers tuned by example, and it also sells pharma services and AWS-hosted HALO Cloud. Tempus's other suites, from Breast Detect to PanCancer Detect, are research use only, and Paige Predict is labeled not for diagnostic procedures. Prostate Detect is authorized only with specific scanners and viewers, so a lab's scanner decides whether Tempus is available to it at all. Tempus bought Paige in August 2025 for $81.25M, mostly in stock.