Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diabetes Mellitus

计划入组 340 人 · 首次发布于 2026 年 1 月 30 日

AI-based Medical Device Validation for Early Melanoma Detection

计划入组 105 人 · 首次发布于 2024 年 1 月 24 日

Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System

计划入组 115 人 · 首次发布于 2025 年 6 月 12 日

AI-09

AI-071

AI-061

NEURO DEVICE GROUP S A

Poland

Ably Medical AS

Norway

Bullfrog AI

United States

FDA's AI Medical Device Regulation Gap Raises Safety Concerns as Healthcare AI Adoption Accelerates

Verily Shuts Down Medical Device Program as Alphabet Pivots to AI-Driven Healthcare Strategy

Regulators Adapt to AI Revolution in Healthcare: MHRA Leads with New Guidance and Sandbox Initiative