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WHERE MEDICAL INNOVATIONS TAKE FLIGHT

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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FAQs: Key facts to know about APS’s preclinical animal models

Whether you’ve contracted for pre-clinical testing before or you’re approaching the process for the first time, you may have key questions about APS’s preclinical animal models and testing capabilities. The scientific community understands the vital importance of conducting the crucial pre-clinical tests before risking similar testing on humans. Through the years animal research has led […]

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New Guidance! FDA New Guidance for Industry, General Considerations for Animal Studies for Medical Devices

On October 14, 2015, FDA released a draft guidance entitled, “General Considerations for Animal Studies for Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff“.  The purpose of this document is, once final, to supercede FDA’s current Guidance entitled General Considerations for Animal Studies for Cardiovascular Devices, which was issued on July […]

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