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, deep learning, or smart algorithms.”
Product family grouping is discussed in Clause 4 of ANSI/AAMI/ISO 11137-2:2013 entitled 'Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose'. This document is designed to provide general requirements and guidance for establishing a product family for radiation sterilization.
While AI has long been relegated to perform tasks like managing medical records and medication management, it has now become an intelligent contributor wherein it can interpret the results on its own, without the need of a physician or ...
