PubMed

Innovation trajectory of Software as a Medical Device: Evidence from the US FDA-approved products.

PMID: 42389386 · 2026-06-29

J, i, a, k, a, n, , Y, u, ;, , J, i, a, j, i, e, , Z, h, a, n, g, ;, , S, h, u, t, o, , M, i, y, a, s, h, i, t, a, ;, , S, h, i, n, t, a, r, o, , S, e, n, g, o, k, u

ЖурналDigital health

Год2026-06-29

PMID42389386

Аннотация

Digital health innovation is reshaping healthcare, with Software as a Medical Device (SaMD) as a critical frontier. However, little is known about how enterprises evolve portfolios within this regulated market. This study uses enterprise-level SaMD product portfolio data to characterize innovation trajectories in SaMD development and assess heterogeneity in these trajectories across enterprise characteristics. We identify 578 FDA-approved products from 289 enterprises (2012-2022) using the OpenF

Официальный источник

Открыть в PubMed →

Данные получены из PubMed / NCBI. Полный текст и наиболее актуальную информацию всегда смотрите в официальной записи.