PubMed

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

PMID：42389386 · 2026-06-29

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期刊Digital health

年份2026-06-29

PMID42389386

摘要

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

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