Buying Guides
How to Choose AI & Diagnostics Software (SaMD)
AI & diagnostics software (also called Software as a Medical Device, or SaMD) refers to FDA-authorized algorithms that analyze clinical data—most often medical images—to detect, triage, quantify, or characterize disease. As of the FDA's December 2025 data update, the agency had authorized more than 1,300 AI devices since 1995, with 258 cleared in 2025 alone—the most in the agency's history. Typical buyers are hospital CIOs/CMIOs, radiology and cardiology service line directors, lab directors, and ASC administrators evaluating tools to speed triage, reduce read times, or augment specialist scarcity.
May 1, 2026Read article