DermaSensor vs KATE

The vendor says its DERM-SUCCESS multi-reader study found 96% sensitivity and 97% NPV for a Monitor result. The vendor's evidence page also lists a prospective UPMC evaluation, which it calls the first independent investigator-initiated US study, with specificity of 9.4% at the lowest cut point. Mednition's 2019 release cites a vendor study claiming triage accuracy up 26.9% (93.2% for high-acuity patients) at Adventist Health White Memorial, still in peer review when announced. Three PubMed papers by Mednition-employed authors do not name the product.

DermaSensor goes to primary care physicians who want a second look at suspicious lesions. KATE goes to emergency department nursing leaders, with Adventist Health White Memorial and Adventist Health Glendale named as customers. The two products read different inputs, a spectroscopy scan of skin and EHR data at triage.

DermaSensor's FDA route was De Novo, decided in January 2024 under 21 CFR 878.1830. KATE Sepsis holds a Breakthrough Device Designation from November 14, 2023, which is not a clearance.