HALO Prostate AI is a CE-IVD certified deep learning-based screening tool that assists pathologists in the identification and grading of prostate cancer in core needle biopsies. The algorithm automatically analyzes all relevant case slides and notifies pathologists of cases with suspicious findings directly in their native workflow. HALO Prostate AI is seamlessly integrated into HALO AP®. For more information, visit the HALO Prostate AI product page.
Regulatory Compliance
Accessing HALO AI Prostate in our CE-marked case management and viewing platform, HALO AP®, provides end-to-end integration to scanners and LIS | LIMS while providing built in compliance and certifications: CE-IVD, FDA 21 CFR Part 11, ISO 13485:2016, HIPAA, and GDPR.
HALO AI Prostate and HALO AP are CE-marked for in-vitro diagnostic use in Europe and the UK. HALO AI Prostate and HALO AP are For Research Use Only in the US and are not FDA cleared for clinical diagnostic use.