Artificial Intelligence: FDA upgrades to conduct research with AI

Among the infinite uses that can be given to artificial intelligence, the regulation of medicines is now added. In this sense, the Food and Drug Administration (FDA) of the United States, launched the Artificial Intelligence program of the Center for Devices and Radiological Health (CDRH) to carry out research that Help ensure patient access to safe and effective medical devices.

Artificial intelligence technologies with machine learning, They have the capacity to produce medical, diagnostic, therapeutic and prognostic recommendations or decisions. Armed with a large amount of data generated during the delivery of healthcare, researchers discovered that AI can be applied in: image acquisition and processing; early detection of diseases; and in more accurate diagnosis, prognosis and risk assessment.

Just as, in identifying new patterns in human physiology and disease progression; the development of personalized diagnostics; and monitoring the response to therapeutic treatment.

It should be noted, This amplitude is expected to continue increasing in the coming yearsWell, this tool can help carry out more rigorous and economical studies.

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However, the implementation of the program poses many challenges to the development of sound evaluation and understanding methods. In this sense, AI-enabled medical devices can be developed according to the availability of more data.

Besides, It is useful to respond to change in data. This represents a major challenge for CDRH as it aims to improve its regulatory controls and appropriate testing methods.

For this reason, The artificial intelligence program still presents some gaps and challenges. Among them, There is a lack of methods that can improve the training of AI algorithms, for limited labeling training and test data.

Also, metrics for performance estimation are missing, reference standards and uncertainty of AI devices. Besides, There are still no methods to evaluate the safety and effectiveness of AI algorithms in continuous learning, nor are there methods for monitoring the post-marketing of AI devices.

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Nevertheless, the goal of the AI ​​program remainsthis consists of filling knowledge gaps through the development of test methods and evaluation methodologies with solid AI, to measure your performance and ensure your safety and effectiveness so you can perform in the real world.

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