Articles tagged with “510-k-clearance”

FDA SaMD Classification: AI & Machine Learning Guide

Understand FDA SaMD classification for AI/ML devices. Review risk levels (Class I-III), 510(k) pathways, and regulatory guidelines for medical software.

20 min read

2/9/2026

fda regulation samd classification ai medical devices machine learning 510(k) clearance de novo pathway software as a medical device regulatory compliance

FDA's AI Medical Device List: Stats, Trends & Regulation

Learn about the FDA's AI/ML medical device tracker. We analyze authorization trends, key statistics by specialty, and the 510(k) regulatory pathway for approval

20 min read

11/10/2025

fda regulation ai in medicine medical devices software as a medical device 510(k) clearance ai in radiology medtech digital health