Medical Device and Diagnostic Industry (MD+DI)

FDA Clarifies When Software & Wellness Products Are Not Medical Devices

FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory ...
Nature

Toward global standards for SaMD: introducing a proposal for Good Digital Medicine Practices (GDMP)

Software as a Medical Device (SaMD) has reshaped the technological, regulatory, and clinical landscape of modern healthcare. Yet regulatory approaches remain anchored to assumptions grounded in ...
PC Tech Magazine

Choosing the Largest Healthcare Software Company for Your IT Upgrade

I have managed software builds across multiple industries. Healthcare projects are brutally unforgiving. If a retail app ...
Medical Device Network on MSN

Subtle Medical lands FDA clearance for AI CT imaging software

SubtleHD(CT) joins Subtle’s other AI medical imaging products including SubtlePET and SubtleHD(MR) that aim to improve PET and MR images, respectively.
Nature

Regulation of clinical Artificial Intelligence (AI) in the Age of Agents: Unconfined Non-Deterministic Clinical Software (UNDCS) systems for healthcare

In a recent article, Weissman et al. 1 examined the extent to which artificial intelligence (AI)-based large language models (LLMs) generate clinical decision support (CDS) outputs that meet the ...