HALO Prostate AI

HALO Prostate AI is a deep learning-based application designed to assist pathologists in the identification and grading of prostate cancer within core needle biopsies. It is seamlessly integrated into the HALO AP® platform, which is an AI-powered, pathologist-driven system for anatomic pathology workflows developed by Indica Labs.

The software is CE-marked for in-vitro diagnostic use in Europe, the UK, and Switzerland, ensuring compliance with regional regulatory standards. However, in the USA, it is designated for Research Use Only and has not received FDA clearance for clinical diagnostic purposes. The HALO AP® platform, which hosts HALO Prostate AI, is also CE-IVDR marked for in-vitro diagnostic use in the same regions and complies with FDA 21 CFR Part 11, HIPAA, and GDPR regulations.

Key Features:

• Deep learning-based screening for prostate cancer detection.
• Gleason grading capabilities to assist pathologists.
• Seamless integration into the HALO AP® digital pathology platform.
• Regulatory compliance in Europe, the UK, and Switzerland.

Indica Labs announced the CE-IVD certification for HALO Prostate AI in May 2022, highlighting its role in advancing computational pathology solutions. For those interested in exploring the capabilities of HALO Prostate AI further, live demos and additional information about clinical solutions are available upon request.