DermaSensor vs Zio

A primary care physician rents DermaSensor to score a suspicious skin lesion, and a cardiology group or health system orders iRhythm's Zio service to monitor a patient's rhythm over days of wear. DermaSensor's FAQ says a dedicated CPT code has not yet been established, and its vendor evidence page lists specificity between 9.4% and 33%. With Zio, a patch is worn and returned, cloud deep learning flags arrhythmias, cardiac technicians validate them, and a physician report follows. iRhythm bills payers through Medicare-enrolled IDTFs, and the vendor claims 99% physician agreement on end-of-wear reports.

On the FDA side, iRhythm has 18 510(k) records. A warning letter dated May 25, 2023 said Zio AT was changed without clearance and marketed to a new high-risk population, Form 483 observations followed July 2024 inspections, and the FY2025 10-K says FDA issues remain open. openFDA shows one DermaSensor record, a De Novo classification as a software-aided adjunctive diagnostic device. DermaSensor reports $43M in total investment, and iRhythm is a public company.