An interpretive software program with image analysis algorithms [e.g., artificial intelligence (AI)-based] intended to be used in a digital pathology or microbiology laboratory to assist in the analysis of clinical specimens (e.g., biopsy, blood smear, urine) and/or microbial cultures for the quantitative/qualitative detection of cell markers (e.g., hormone receptors), changes in tissue architecture and/or cell morphological/physiological characteristics [e.g., nucleus size, cytoplasmic granularity, rate of cell division], and/or infectious microorganisms associated with a disease (e.g., breast cancer, malaria, UTI). Results are also interpreted by a clinician to guide patient management.
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