Prenosis says AI tool for sepsis approved by FDA

107038297 16485676582022 03 29t152000z 2042485378 rc2fct9i1zyo rtrmadp 0 health coronavirus usa boosters

107038297 16485676582022 03 29t152000z 2042485378 rc2fct9i1zyo rtrmadp 0 health coronavirus usa boosters

Health technology company, Prenosis, shared on Wednesday that its artificial intelligence-driven diagnostic tool for sepsis has become the first to obtain approval from the U.S. Food and Drug Administration. Sepsis, an extreme reaction of the body to infection, proves to be highly lethal, causing the death of over 350,000 hospitalized adults, or their discharge to hospice every year as per the Centers for Disease Control and Prevention. The disease, challenging to diagnose, necessitates quick detection as patients may worsen rapidly.

Termed as Sepsis ImmunoScore, Prenosis’ tool utilizes 22 different indices such as temperature, heart rate, and cell counts to aid doctors in speculating a patient’s risk of sepsis. The tool, as opposed to the individual monitoring of various parameters by doctors and nurses, employs AI to assess all these indicators simultaneously. The tool provides an overall risk score and four categories that correlate to the patient’s risk of deterioration, the company shared with CNBC.

With its foundation on Prenosis’ Immunix platform, the Sepsis ImmunoScore has been developed using data from more than 100,000 blood samples drawn from 25,000 unique patients. The tool can be directly integrated into electronic health records, allowing clinicians to create and manage patient medical records. This feature makes it convenient for use and access, aside from displaying the parameters used to calculate the overall risk score.

This AI diagnostic tool for sepsis is a significant achievement for the decade-old startup based in Chicago, having received approval through the FDA’s De Novo pathway. The pathway signifies the FDA’s prior non-authorization of any similar device as the Sepsis ImmunoScore.

While Prenosis is the pioneer in obtaining FDA approval for the AI diagnostic tool for sepsis, several other organizations have also developed similar solutions. For instance, Johns Hopkins University has designed an AI system to detect sepsis symptoms more quickly. A 2022 study in Nature Medicine revealed that this AI model could detect sepsis six hours earlier than conventional methods in critical cases.

Prominent healthcare software vendor, Epic Systems, also created an AI-powered sepsis prediction tool, albeit being subject to considerable criticism in recent years. However, Epic claimed that healthcare organizations had observed improved sepsis mortality rates owing to its technology, as stated in a company blog post. Following the criticisms, Epic reportedly revamped its sepsis model the next year to boost its performance.

Despite having developed the Sepsis ImmunoScore about three years ago, Prenosis preferred to wait for FDA approval to ensure the tool’s safety and efficacy. Prenosis stated that it had proven the safety and efficacy of the Sepsis ImmunoScore to the FDA over around 18 months. Following the approval, Prenosis intends to undertake more studies to show the tools’ precision and influence on clinical decision-making, subsequently selling the tool to hospitals in the U.S. and eventually, globally.

Prenosis, a health technology company, recently announced that the U.S. Food and Drug Administration (FDA) has approved its artificial intelligence (AI)-powered diagnostic tool for sepsis, making it the first of its kind to receive such approval. Sepsis, a severe response to an infection that often leads to death, proves difficult to diagnose, with 350,000 adults dying during hospitalization or being discharged to hospice each year.

The diagnostic tool, Sepsis ImmunoScore, evaluates 22 parameters including temperature, heart rate and cell counts to gauge a patient’s risk of sepsis. Prenosis’ AI system examines all these markers simultaneously, offering a comprehensive risk score and four categories that correspond to patient deterioration risk.

Sepsis ImmunoScore, developed using the Immunix platform, is based on over 100,000 blood samples from 25,000 patients. The tool integrates directly into electronic health records, allowing clinicians easy and instant access. Clinicians are provided a display of the parameters used to calculate the risk score, facilitating transparency.

Prenosis’ AI tool obtained approval through the FDA’s De Novo pathway, marking a significant achievement for the decade-old Chicago-based startup. Although Prenosis is the first to receive FDA approval, Johns Hopkins University and Epic Systems have also developed similar AI sepsis detection models.

Despite successfully securing regulatory approval now, Sepsis ImmunoScore was ready for market three years ago. However, Prenosis opted to pursue FDA approval to ensure that the tool met safety standards and posed no harm. Prenosis now plans additional studies to further validate the tool’s accuracy and impact on clinical decision-making before beginning to sell the tool to U.S. hospitals, broadening the scope to global hospitals eventually.

Source link

Leave a Reply

Your email address will not be published. Required fields are marked *

scroll to top