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
HALO AI Prostate is CE-marked for in-vitro diagnostic use in Europe, the UK, and Switzerland. HALO AI Prostate is For Research Use Only in the USA and is not FDA cleared for clinical diagnostic use. HALO AI Prostate is accessed via the HALO AP® enterprise digital pathology platform.
HALO AP® is CE-IVDR marked for in-vitro diagnostic use in Europe, the UK, and Switzerland. HALO AP is For Research Use Only in the USA and is not FDA cleared for clinical diagnostic use. In addition, HALO AP provides built-in compliance with FDA 21 CFR Part 11, HIPAA, and GDPR.