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. With 1,451 devices authorized through 2025 and 295 cleared in 2025 alone, we analyze authorization trends, specialty breakdown, foundation model milestones, and the evolving regulatory framework

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