Categories: Blog
Published 15 May 2024
Deray Global Utama

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

On October 5, 2022, the Food and Drug Administration (FDA) released an update indicating that 178 medical devices utilizing artificial intelligence and machine learning (AI/ML) have been added to the Software as a Medical Device (SaMD) list. This update also enables users to download the list as Excel files. It includes general information about AI/ML-enabled devices, highlighting the growing importance of AI, particularly the branch known as Machine Learning (ML), in enhancing healthcare technologies.

One of the main advantages of ML is its capacity to extract valuable insights from the vast amounts of data generated daily in healthcare settings. In recent years, there has been a marked increase in interest regarding medical devices that incorporate ML capabilities.

The FDA has reviewed and approved a growing number of devices that have been legally sold through 510(k) clearances, De Novo requests, or PMA approvals, all featuring ML technology. They anticipate that this trend will continue to expand.

To inform the public about these devices and the FDA's initiatives in this area, the FDA has compiled a list of AI/ML-enabled medical devices available for sale in the United States. This list includes publicly accessible information obtained from various sources and documents provided by each manufacturer.

It is important to note that this list is not intended to be exhaustive; rather, it serves as a reference for medical devices that utilize AI and machine learning, based on publicly accessible data. The FDA plans to periodically update this list as new information becomes available.

For full details, read the original source from the Health Sciences Authority.

For inquiries regarding the registration of medical devices.