Paige announces first ever CE mark for deep learning in pathology

Paige announces first ever CE mark for deep learning in pathology

Press releases may be edited for formatting or style | November 12, 2019 Artificial Intelligence Health IT
NEW YORK, Nov. 12, 2019 /PRNewswire/ -- Paige, the leader in clinical-grade computational pathology, today announced CE Mark for Paige Prostate, its first-in-class prostate cancer detection solution, along with Paige Insight, its AI-native digital pathology viewer, both for primary diagnosis. The solutions are vendor neutral and allow for seamless collaboration across teams and sites. With CE Mark, these solutions will be available to European pathology practices, many of which are facing increased case volumes and shortages of qualified pathologists.

Giving Pathologists More Information

Pathology is the cornerstone of pivotal diagnoses for patients, especially in cancer. This essential practice faces challenges from lower reimbursement and increased productivity demands, yet the tools used in practice have changed little in the last decade. Today, most pathology assessments are performed by viewing glass slides with microscopes, and second opinion requests require shipping these fragile samples between sites. Digitizing the practice of pathology presents big opportunities for advancing the field, yet the lack of interoperability between fragmented solutions and insufficient efficiency gains have hindered its general adoption.


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Paige's offerings enable pathologists to overcome these barriers: Insight allows pathologists to view, process and collaborate on whole digitized slides from different sites and scanners, while leveraging the power of Paige's AI-based modules with the potential to provide improved diagnostic quality, higher pathology throughput and lower costs. The first of these, Paige Prostate, has achieved clinical grade accuracy: demonstrating equivalent performance in images taken with multiple scanners and on slides prepared at hundreds of institutions.

CE Mark is an important milestone for Paige," said Dr. Leo Grady, CEO. "Pathology practices around the world have begun to embrace digital pathology and can begin to realize the potential of the technology with real-time quality assurance, gains in productivity, and improved collaboration across sites. We believe in empowering pathologists with additional insights from these rich pathology images, so they can make more effective, confident diagnoses."

Modern software for critical decisions

Prostate cases are among the most difficult and time-consuming biopsies for pathologists to review, grade, and report. The assessment is nuanced and requires close inspection of many tissue samples. This difficult assessment can lead to discordance in findings between pathologists as well as diagnostic errors. In one study, 9% of cases received for a second opinion at a leading institution resulted in revisions to original findings1. Current guidelines require re-review of a small percentage of cases since additional reviews of all cases and slides by qualified pathologists would be economically and practically unfeasible.

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