HALO PROSTATE AI

HALO Prostate AI, from Indica Labs, is a CE-IVD certified deep learning based screening tool designed to assist pathologists in the identification and grading of prostate cancer in core needle biopsies. The algorithm automatically analyzes all appropriate case slides and notifies pathologists of cases with suspected findings directly in their native workflow.

Comprehensive Analysis Results

The algorithm reports a comprehensive set of results and markups, including cancer detection and localization, tumor size, Gleason grading, the presence of high-grade PIN and intraductal carcinoma.

Seamlessly Integrated, AI-Enhanced Workflow

• CE-IVD marked with best-in-class clinical sensitivity and specificity
• Deploy as a screening tool to support triage or as a post-diagnostic QC-check
• Results can be shared with LIS/LIMS systems from any vendor
• Deploys in your own IT environment – cloud or on-premise – so you maintain full control of the data
• Extend your image analysis capability with further integration of IHC image analysis from Indica Labs

Regulatory Compliance

Accessing HALO Prostate AI 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 13485:2017, HIPAA, and GDPR.

* HALO Prostate AI and HALO AP are CE-IVD marked for diagnostic use within the European Economic Area, Switzerland, and the UK and is For Research Use Only in the USA.

HALO PROSTATE AI

HALO Prostate AI, from Indica Labs, is a CE-IVD certified deep learning based screening tool designed to assist pathologists in the identification and grading of prostate cancer in core needle biopsies. The algorithm automatically analyzes all appropriate case slides and notifies pathologists of cases with suspected findings directly in their native workflow.

Comprehensive Analysis

The algorithm reports a comprehensive set of results and markups, including cancer detection and localization, tumor size, Gleason grading, the presence of high-grade PIN and intraductal carcinoma.

Seamlessly Integrated, AI-Enhanced Workflow

• CE-IVD marked with best-in-class clinical sensitivity and specificity
• Deploy as a screening tool to support triage or as a post-diagnostic QC-check
• Results can be shared with LIS/LIMS systems from any vendor
• Deploys in your own IT environment – cloud or on-premise – so you maintain full control of the data
• Extend your image analysis capability with further integration of IHC image analysis from Indica Labs

Regulatory Compliance

Accessing HALO Prostate AI 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 13485:2017, HIPAA, and GDPR.

* HALO Prostate AI and HALO AP are CE-IVD marked for diagnostic use within the European Economic Area, Switzerland, and the UK and is For Research Use Only in the USA.

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