The FDA approved the Prenosis’ solution through its De Novo Pathway, meaning it is the first of its kind to be granted approval Credit: Getty Images / Bet_Noire

Health technology company Prenosis announced on Wednesday (3 April) that its AI-powered diagnostic tool for sepsis is the first to receive approval from the US Food and Drug Administration (FDA).

Prenosis’ Sepsis ImmunoScore tool uses 22 different parameters, including temperature and heart rate, to aid health professionals in assessing a patient’s risk of sepsis. 

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The tool makes it easier for health workers to detect sepsis by grouping all of the parameters together with AI whereas clinicians usually have to monitor each parameter separately. 

According to Prenosis, the AI-powered tool will generate a patient’s overall risk score and provide four categories that “correlate to a patient’s risk of deterioration.” 

Sepsis is the body’s extreme response to an infection and is classed as a life-threatening medical emergency. Over 350,000 adults with sepsis die during hospitalisation or are discharged to a hospice annually, according to data from the Centers for Disease Control and Prevention. 

The early detection of sepsis is paramount to a patient’s survival due to how quickly the condition can become fatal. 

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Prenosis built the Sepsis ImmunoScore using its Immunix Platform, which houses a dataset of over 100,000 blood samples from 25,000 patients. 

The Chicago-based startup said the tool is integrated directly into health records where medical professionals create patients’ medical records. Prenosis said this will make it easy to use and access. 

The FDA approved the solution through its De Novo Pathway, meaning it is the first of its kind to be granted approval, despite other companies having created similar solutions.