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The importance of rigorous ACT management during preclinical study procedures

During the preclinical testing of medical devices, one data point that regulatory officials are scrutinizing is the activated clotting time (ACT) of the animal model. ACTs are measured periodically while an invasive device is inserted in the vasculature This allows lab staff to monitor clotting time before and after the anti-coagulant (e.g. heparin) has been […]

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Pathology Matters, part 2 of a 3 part series: Assessing Histopathology Results

Part 1 of this series described the preclinical study types relying heavily on histopathology data: device safety, biocompatibility, and systemic toxicity. Here we focus on strategies for histopathology data assessment. Preclinical study histopathology data can generally be divided into three types: Qualitative Quantitative Semiquantitative Qualitative histopathology uses description to document tissue changes and is more […]

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Pathology Matters, part 1 of a 3 part series: Preclinical Studies and Histopathology

The histopathology evaluation in preclinical studies is performed to support the study objectives. The study type, tissues examined, and intended data use all determine what pathology analysis is needed. Here we review the preclinical studies that rely heavily on histopathology data. Histopathology is a key component of these preclinical study types: Device safety studies Biocompatibility […]

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