Predicting late-onset sepsis in the NICU

It turns the signals your NICU already records into one explainable risk score for late-onset sepsis. The index is recalculated every 30 minutes and always shows which parameters are pushing it up or down, so a nurse or neonatologist can see why the score moved and not only that it moved. In the retrospective validation it flagged late-onset sepsis a median of 11 hours before it was clinically suspected.

No. Intellicens Neo reads the same signals as the bedside monitor but changes nothing about it: the monitor keeps working exactly as it does today, and Intellicens Neo adds no bedside alarms. It is a second read on the same physiology that brings a suspicion forward in time, not a diagnosis. The clinical decision stays with the clinician.

Intellicens Neo is under clinical investigation and is not yet available for clinical use. It is not CE marked under EU MDR 2017/745 and has not been cleared by the U.S. Food and Drug Administration. It is developed under an ISO 13485 quality management system and follows the Class IIb route under EU MDR 2017/745 with BSI as notified body, and in the United States the 510(k) pathway is defined with a pre-submission filed. Installations today run as research or evaluation deployments under the agreement with the hospital.

It runs on continuous vital sign data your monitors already produce, together with context from the electronic medical record, over the HL7 and FHIR interfaces your hospital already operates. It requires no new hardware at the bedside. The platform is installed on-premise, so patient data does not leave your perimeter. Access runs through your own identity provider.

Retrospectively first, in the NICU where it was developed, published as Meeus et al. 2024. It was then validated externally in an independent multicenter cohort of more than 1,100 infants at Erasmus MC and Amsterdam UMC, which reproduced the lead time (publication under peer review). A prospective pre- and post-implementation study on times-to-antibiotics is the next step, because lead time on a curve and changed behavior at the bedside are two different claims.

It is built not to. Intellicens Neo raises no audible alarm at the bedside. The risk score and the parameters driving it are shown in a dashboard, next to the rest of the patient's data, and in the retrospective validation the score produced fewer than one alert per patient per week (Meeus et al. 2024).

It takes an on-premise installation of the Intellicens Data Platform, connectors to your monitors and your EMR, a data governance agreement with your data protection officer, and a short training round with the clinical team. Nothing is added at the bedside. Because the platform is installed once, adding further applications later does not repeat that work.