REGULATORY UPDATE | MEDICAL DEVICES SUPPORTED BY ARTIFICIAL INTELLIGENCE (AI) AND MACHINE LEARNING (ML)

On October 5, 2022, the Food & Drugs Administration (FDA) released an update that 178 medical devices that can use artificial intelligence and machine learning (AI/ML) have been added to the Software as a Medical Device (SaMD) list. The FDA has also made it possible to download lists as Excel files with this update. This update contains general information about AI/ML enabled devices. Software that uses artificial intelligence (AI), and more specifically the branch of AI known as Machine Learning (ML), has become an important part of the growing number of medical devices as technology continues to improve every area of healthcare.

One of the main potential advantages of ML is its ability to extract significant new insights from the vast amounts of data created every day during the provision of healthcare. In recent years, there has been an increasing interest in medical devices with ML capabilities.

The FDA has reviewed and approved an increasing number of devices that have been legally sold (via 510(k), granted De Novo request, or PMA approved) with ML over the previous ten years, and they anticipate that this trend will continue.

As a resource for the general public about these devices and the FDA's efforts in this area, the FDA listed these AI/ML-enabled medical devices available for sale in the United States.

This list of AI/ML enabled gadgets includes publicly accessible information. The FDA compiled this list by seeking publicly accessible data, as well as information from publicly accessible sources listed below (*) and additional publicly accessible documents released by each manufacturer.

This list is not intended to be an exhaustive or exhaustive reference it is a list of medical devices that use AI and machine learning, based on freely accessible data. Based on information currently in the public domain, the FDA intends to periodically update this list.

Read full information at the original source Health Sciences Authority

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