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Improving Targeting Precision and Field Force Direction through AIML-based Patient Finding

Background A global rare disease company was looking to improve targeting precision and support field team effectiveness Traditional targeting was non-viable due to the small size of the patient populations, complex disease recognition and diagnosis, and restrictive therapy eligibility criteria Attempts by a prior analytics partner to use rule-based alerts failed, and even after two years, no new patients had been identified Given the small number of patients in each indication, every new start is high value, both for the…

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AI-Based Software Paige Prostate is Granted FDA Approval Through the De Novo Regulatory Pathway

Published September 27, 2021

Paige Prostate is the first artificial intelligence (AI)-based software designed to identify areas of concern (i.e., high likelihood of containing cancer) on a prostate biopsy image so they can be flagged for further review by a pathologist. The program is intended to be used as an adjunct tool to the review of digital scanner slide images from prostate biopsies. The program was reviewed through the De Novo pathway, a regulatory pathway for low-to-moderate risk novel devices. The FDA authorization is based…

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