AI Continues to Gain Traction in the Medical Device Industry

Release date:2024-05-10 Source: Author: Elise Reuter

Here are five key insights from the FDA's latest update on cleared AI/ML medical devices:


1. Submission Rates: After a slowdown in 2021 and 2022, FDA submissions for AI/ML devices are on the rise again, expected to surpass 30% growth this year.


2. Leading Companies: GE HealthCare and Siemens Healthineers topped the list for the most cleared AI/ML devices between August 2022 and July 2023, with GE HealthCare having the most authorized devices overall.


3. Dominance of Radiology: Radiology continues to be the primary area for AI/ML devices, representing 87% of new devices last year and 79% in the first half of 2023, driven partly by early digitization of imaging data.


4. Generative AI Absence: None of the cleared devices on the list utilized generative AI or artificial general intelligence, with the FDA noting a variety of models used, from shallow to deep learning approaches.


5. Regulatory Pathway: The majority of devices cleared in the recent period followed the FDA's 510(k) pathway, consistent with historical trends where 96% of AI/ML devices cleared between 1995 and 2022 followed the same pathway.