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Current State of the Regulatory Trajectory for Whole Slide Imaging Devices in the USA
The regulatory field for digital pathology (DP) has advanced significantly. A major milestone was accomplished when the FDA allowed the first vendor to market their device for primary diagnostic use in the USA and published in the classification order that this device, and substantially equivalent d...
Autores principales: | Abels, Esther, Pantanowitz, Liron |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Medknow Publications & Media Pvt Ltd
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5450449/ https://www.ncbi.nlm.nih.gov/pubmed/28584684 http://dx.doi.org/10.4103/jpi.jpi_11_17 |
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