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FDA approves first AI sepsis detection tool, announced by Prenosis

FDA approves first AI sepsis detection tool, announced by Prenosis

 


top line

US Food and Drug Administration approved Prenosis, the company behind the software, an AI tool that can diagnose sepsis, announced a series of updates on Wednesday. agency approval For AI diagnostic tools.

important facts

The Sepsis Immune Score uses 22 diagnostic and predictive parameters to calculate a patient's risk of developing sepsis within 24 hours, according to a press release. This combination of criteria “has not previously been available in legally marketed equipment” for this condition.

The tool is integrated into hospitals' electronic health records and is from a Chicago-based startup. Immunix platforma dataset containing over 100,000 blood samples from over 25,000 patients.

The Sepsis Immune Score was approved through a government agency. route againthe process the FDA uses for new medical devices.

Plenosis spokesperson Gary Poole told Forbes that the company plans to sell the Sepsis Immune Score in hospitals across the country, adding that the company plans to announce “sales partnerships with major diagnostic companies next week.” .

big number

At least 350,000.That's about it for adults People who develop sepsis die According to the Centers for Disease Control and Prevention, each year, some people outgrow the condition or are discharged to hospice care.

Main background

Sepsis is a life-threatening condition that occurs as an extreme reaction to a pre-existing infection. at least 1.7 million According to the CDC, the number of cases is increasing every year. early signs These include fever, rapid heart rate, shortness of breath, and confusion. According to , the condition can be difficult to diagnose because it progresses rapidly and often presents as a common infection. ale medicine.some groups are at higher risk According to the CDC, the number of people who develop sepsis, including adults age 65 and older and patients who survive an attack of sepsis. The agency granted his Prenosis tool its first marketing approval, but other systems such as Epic Health have released similar tools. The efficacy of Epic's sepsis model is scrutinized in multiple the study According to reports, since its launch in 2021 Improved In 2022.

tangent

On Tuesday, the FDA cleared An algorithm developed by Mayo Clinic and startup Eco Health could help doctors predict heart failure. This algorithm helps Eko Health's digital stethoscope detect: low ejection fractionoccurs when the heart's left ventricle is not pumping enough blood during contraction.

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References

New algorithm for AI stethoscope to predict heart failure receives FDA approval (Forbes)

FDA approves AI-powered handheld device that can detect skin cancer (Forbes)

Research throughout early pandemic points to the importance of surveillance for viral sepsis (Forbes)

Epic overhauls popular sepsis algorithm criticized for alarm flaws (STAT News)

Sources

1/ https://Google.com/

2/ https://www.forbes.com/sites/caileygleeson/2024/04/03/fda-approves-ai-tool-that-can-detect-sepsis/

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