181030-SC2-Results-FINAL ResAppDx achieved a positive percent agreement (PPA) between 73% and 78% and a negativepercent agreement (NPA) between 71% and 86% when compared to a clinical diagnosis forlower respiratory tract disease, asthma/reactive airway disease (for children over 2 years of age)and primary upper respiratory tract disease. ResApp intends to submit a de novo premarketsubmission to the United States Food and Drug Administration (FDA) for approval in these threeindications. Results for pneumonia and bronchiolitis were less than 70% at this stage andsubmission for these diseases will occur in a second phase.
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181030-SC2-Results-FINAL ResAppDx achieved a positive percent...
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #
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