07 May, 2024 Exploring Regulatory Hurdles: How to Navigate FDA Approval for AI-Enabled Medical Devices By Austin Kim This article provides an overview of the FDA's approval process for AI-enabled Software-as-a Medical-Device (SaMD). Under the current...
31 Jan, 2024 FDA/CDRH's Take on the Growing Importance of Transparency in AI/ML-Enabled Medical Devices By Austin Kim Beyond traditional regulatory concerns, the U.S. Food and Drug Administration (FDA) is currently navigating the challenges of usability,...
24 Oct, 2023 Will Generalist Medical AI Solve Current Limitations in Clinical AI Tools? By Austin Kim The integration of clinical AI tools into health care faces both skepticism and potential promise. Many physicians, although aware of...