Ceribell vs DermaSensor

DermaSensor is offered on monthly rental, with purchase terms by discussion. A primary care practice gets a one-year device use agreement with a try-and-return option and training included, per the FAQ, and the vendor says no dedicated CPT code exists yet. The FAQ states no rental or purchase price. The FDA route is De Novo, DEN230008, for physicians using it on lesions already suspicious for skin cancer. Vendor figures show 96% sensitivity in the DERM-SUCCESS multi-reader study but 33% specificity in DERM-ASSESS III, a multicenter prospective blinded study, and 9.4% at the lowest cut point in a UPMC study. A primary care practice renting a handheld lesion reader and an ICU buying a bedside EEG recorder are shopping for different products.

Ceribell sells to hospitals under order contracts. Fees are paid in advance on net 30 terms, the one-year initial term renews yearly unless the hospital gives 90 days' notice, and a lost loaned recorder costs $2,500. Its buyers are ICUs and emergency departments that need seizure detection on a bedside EEG, and openFDA lists sixteen Ceribell 510(k) records.