Emergency_medicine
Sepsis ImmunoScore
Prenosis, Inc.
FDA
FDA-cleared AI medical device
Software that draws on up to 22 predetermined inputs from the patient's electronic health record to generate a risk score and assign one of four risk-stratification categories, intended to aid assessment of the presence of or progression to sepsis within 24 hours of patient evaluation, used alongside other laboratory findings and clinical judgment.
FDA Submission Metadata
- Submission number
- DEN230036
- Decision date
- April 2024
- FDA panel
- General Hospital
- Product code
- SAK
- Clinical task (npj)
- predictive
- Data modality (npj)
- EHR
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA