FDA Authorizes First AI-Enabled Test to Predict Sepsis
Summary
On April 5, 2024, the Food and Drug Administration (FDA) gave the green light to the first AI-enabled diagnostic tool for sepsis. Roughly 1.7 million adults in the U.S. develop sepsis each year, and nearly 270,000 die as a result. Prenosis Inc.'s Sepsis ImmunoScore device uses data from the patient’s electronic health record in conjunction with other laboratory findings and clinical assessments to aid in risk assessment for presence of or progression to sepsis. In line with the FDA's approach to AI-driven medical devices thus far, the De Novo authorization for this device establishes specific postmarket requirements.
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Additional Information
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