AI tool gains FDA emergency approval to help treat COVID-19 patients: 4 details

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Just a few artificial intelligence models have received FDA emergency use authorization to help clinicians diagnose and treat COVID-19, the latest being an algorithm designed by Oakland, Calif.-based digital health company Dascena.

Four details about the algorithm:

  1. The algorithm, named the COViage Hemodynamic Instability and Respiratory Decompensation Prediction System, predicts the likelihood hospitalized COVID-19 patients will need intubation.

  2. During spring, Dascena tested the AI tool in a clinical trial involving 197 hospitalized COVID-19 patients across five U.S. hospitals. The study found that the algorithm performed more effectively than the Modified Early Warning Score, a rules-based system that is not AI-reliant but is commonly used by clinicians to help assess COVID-19 patients' needs, according to STAT.

  3. The FDA granted emergency use authorization to the algorithm Sept. 24.

  4. In the letter the FDA wrote to establish the algorithm's emergency approval, it warns that the tool is not "intended to be used on a standalone basis for clinical decision-making."
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