Sepsis ImmunoScore

What exactly did the FDA authorize?

The record reads DEN230036, "Sepsis ImmunoScore", requester Prenosis, Inc. of Chicago, IL, product code SAK, under 21 CFR 880.6316, a "software device to aid in the prediction or diagnosis of sepsis". No K number appears for the company. "The first-ever FDA-authorized AI diagnostic for sepsis" is the vendor's wording.

How does the score work?

The vendor says the model takes up to 22 parameters from the EHR, including age, vital signs and labs such as procalcitonin, CRP and lactate, and returns a low, medium, high or very high band for deterioration risk within 24 hours. The intended population is adults 18 and over admitted to the ED or hospital with suspected sepsis, meaning a blood culture has been ordered.

The vendor says the score is meant "not as a replacement of clinical judgment" and that it "has not been validated for use in certain inpatient settings such as ICU or Labor and Delivery units". The model is locked, with no continuous learning, and the vendor describes drift monitoring after go-live. The score appears in a "Sepsis Patient View" inside the EHR, and no EHR vendor is named.

What have the papers shown, and who wrote them?

A 2024 NEJM AI article, "FDA-Authorized AI/ML Tool for Sepsis Prediction: Development and Validation" (PMID 42932768), carries Prenosis authors according to the vendor's page. Two 2026 papers are on the vendor's list: one in Diagnostics titled "The Sepsis ImmunoScore Predicts Sepsis, Mortality, and Deterioration Better than Clinical Scores and Widely Available Biomarkers" (PMID 42449744), and one in JAMIA Open on SHAP-based interpretability (PMID 41767180). Two further 2026 papers (PMID 41680670 and PMID 42459343) are reviews of AI for sepsis that mention the tool without studying it.

The vendor lists an OBSERVE-ARDS study at Carle Health, where the homepage also announces a deployment.

How is it paid for?

Prenosis lists no price and offers demo or contact routes only. The vendor says sepsis falls under a DRG with no separate payment, and that a new ICD-10-PCS code for AI sepsis diagnostic tools took effect on October 1, 2025.

Who is Prenosis?

Bobby Reddy Jr., PhD, is co-founder and CEO. Meghann Howland is chief clinical officer. The company also runs a biobank, which it puts at more than 140,000 longitudinal biospecimens from over 35,000 patients, along with trials and a therapeutics pipeline. An Investors page is linked, and no round, amount or date is stated. Its product pages list no privacy or security certificate.

The verdict

Sepsis ImmunoScore fits an ED or inpatient service that wants an authorized score beside clinical judgment. Because the intended use starts at a blood culture order, the score applies after a clinician already suspects sepsis. The De Novo covers a software device to aid in the prediction or diagnosis of sepsis under 21 CFR 880.6316. The vendor separately limits intended use to adults 18 and over with suspected sepsis and a blood culture order, and says the score has not been validated in ICU or labor and delivery.