A snapshot of the regulations for Artificial Intelligence in medical devices

Artificial Intelligence: The Game Changer of Medtech (MDDI Online)

The year 2018 has seen a good influx of innovative medical devices. Artificial intelligence (AI) serves as a critical component in most of these novel devices.

FDA has defined artificial intelligence as: “A device or a product that can imitate intelligent behavior or mimics human learning and reasoning. Artificial Intelligence includes machine learning, neural networks, and natural language processing. Some terms used to describe artificial intelligence include: computer-aided detection/diagnosis, statistical learning, ...


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