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FDA Approves AI Tool for Quick Sepsis Diagnosis

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Prenosis revealed that the Sepsis ImmunoScore, a new artificial intelligence (AI) software, has received approval from the FDA for diagnosing sepsis rapidly. This tool integrates into electronic health records and utilizes 22 biomarkers and patient data to offer diagnostic and predictive information within just 24 hours of patient assessment in emergency departments or hospitals.

The AI tool calculates a risk score and divides patients into four distinct risk categories, helping clinicians understand the likelihood of deterioration, in-hospital mortality, and the need for intensive care unit (ICU) admission within a day.

Bobby Reddy, Jr., PhD, the co-founder and CEO of Prenosis, expressed excitement about the FDA’s approval, calling it a significant development for individuals at risk of sepsis. The authorization came through the FDA’s de novo pathway, supported by a study conducted in 2021 involving 1,400 adult patients suspected of sepsis in emergency departments.

FDA Approves AI Tool for Quick Sepsis Diagnosis

The study showed that the AI tool accurately identified sepsis and predicted outcomes such as discharge time, 30-day mortality, and inpatient re-admission. Patients with septic shock and organ dysfunction had higher predicted risk scores compared to those with sepsis alone.

Sepsis is a severe condition affecting millions in the United States annually, with a substantial number succumbing to it. Early treatment with antibiotics can improve outcomes, but recognizing sepsis promptly remains a challenge due to vague symptoms and the need for thorough evaluation.

Prenosis developed the Sepsis ImmunoScore using its proprietary Immunix platform, which contains a vast dataset of blood samples from thousands of patients. Reddy believes that this platform could revolutionize healthcare by guiding the creation of precision therapeutics through AI diagnostics, extending beyond emergency departments and hospitals.

Source: Medpagetoday