As the number of devices increases, the agency is looking to adapt its regulatory framework to the new technology, including faster approval of algorithm updates.
As medical devices that use artificial intelligence and machine learning appear in more hospitals and imaging labs across the U.S., new data from the Food and Drug Administration show the agency has been fielding more submissions.
In 2022 alone, the FDA authorized 91 AI- or machine-learning-enabled medical devices, according to data released on Oct. 5. This broad category of devices can include anything from a basic algorithm to more complex machine learning tools, Michaela Miller, U.S. medtech technology and analytics practice leader for IQVIA, a North Carolina-based analytics and clinical research firm, said by email.
MedTech Dive analyzed FDA data on all of the AI- and machine-learning-enabled devices the agency has authorized to date. Follow this link to the full article to read the five takeaways on the rise of these devices.