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Medical Devices

A medical device is defined as any instrument, apparatus, machine, appliance, implant, reagent for in vitro use, software, material or other similar artifacts intended by the manufacturer to be utilized, alone or in combination, for a medical purpose. This term includes a wide variety of items such as a pacemaker, Band Aid, cotton swab, thermometer, nebulizer, glucose meter, insulin pump, to highlight a few common items. Medical devices are widely used across all sectors of health applications—from injury prevention and recovery to disease diagnostics and emergency room surgery. Likewise, exosomes have the potential to help advance the application, safety, and/or efficacy of medical devices in these sectors of healthcare interventions. Exosomes may be added into the design of existing medical devices, incorporated into novel medical devices, or used as biomarkers of disease states in testing kits. For example, stem cell derived exosomes can be incorporated into bone or skin scaffolds used to treat patients after orthopedic injuries or burns. Incorporation of exosomes in medical devices used in animal studies is shown to increase wound healing potential, angiogenesis, enhance cellular proliferation, decrease time of recovery, etc.

Exosomes contain valuable biological information such as proteins, peptides, lipids, metabolites, and nucleic acids, that may be of great interest in the development of diagnostic test kits for biomarker discovery and identification. During the development and progression of different disease states, exosomes from different biological fluids are shown to have differential nucleic acid/protein expression profiles and therefore altered biological function. A disease or sickness testing kit can be designed to assay for a specific exosome subpopulation, a certain molecule encapsulated within an exosome, or a molecule presented on the exosome surface that may be indicative of a disease state or illness. A testing kit that profiles exosomes for disease identification, or a pacemaker that includes a dose of cardiomyocyte derived exosomes for surgical recovery, are other examples of how exosomes may be used in medical devices.

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