DermaSensor vs Epic Sepsis Model

DermaSensor is a handheld spectroscopy device a primary care physician uses on a lesion already judged suspicious, and the Epic Sepsis Model is a risk score Epic's EHR calculates for admitted patients. DermaSensor holds De Novo DEN230008, decided in January 2024, as a software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer. It takes five spectral recordings per lesion and returns Monitor or Investigate Further with a 1 to 10 score. The vendor-run DERM-SUCCESS study reports 96% sensitivity, and the vendor's evidence page lists specificity of 33% in DERM-ASSESS III. Its FAQ says EHR integration is not available yet.

The sepsis model runs only inside Epic. Hospitals that license Epic buy it and primary care practices buy DermaSensor, so the two do not share a buyer. An independent four-system validation of version 2 in JAMA Network Open (2026) reported encounter-level AUROC of 0.82 to 0.92 and positive predictive value of 0.13 to 0.26. openFDA lists no 510(k) for the Epic Sepsis Model, and Epic's cleared Deterioration Index Version 2, K260008, is a different model.