The state of artificial intelligence-based FDA-approved medical devices and algorithms: An online database (Preprint)

Abstract

<sec> <title>BACKGROUND</title> At the beginning of the artificial intelligence (A.I.) era, the expectations are high, and experts foresee that A.I. shows potential for diagnosing, managing and treating a wide variety of medical conditions. However, the obstacles for implementation of A.I. in daily clinical practice are numerous, especially regarding the regulation of these technologies. </sec> <sec> <title>OBJECTIVE</title> Therefore, we provide an insight into the currently available A.I.-based medical devices and algorithms that have been approved by the U.S. Food &amp; Drugs Administration (FDA). We aimed to raise awareness about the importance of regulatory bodies, clearly stating whether a medical device is A.I.-based or not. </sec> <sec> <title>METHODS</title> Cross-checking and validating all approvals, we identified 64 A.I.-based, FDA approved medical devices and algorithms. Out of those, only 29 (45%) mentioned any A.I.-related expressions in the official FDA announcement. </sec> <sec> <title>RESULTS</title> The majority (85.9%) was approved by the FDA with a 510(k) clearance, while 8 (12.5%) received de novo pathway clearance and one (1.6%) premarket approval (PMA) clearance. Most of these technologies, notably 30 (46.9%), 16 (25.0%) and 10 (15.6%) were developed for the fields of Radiology, Cardiology and Internal Medicine / General Practice respectively. </sec> <sec> <title>CONCLUSIONS</title> We launched the first comprehensive and open access database of strictly A.I.-based medical technologies that have been approved by the FDA. The database will be constantly updated. </sec>

Ähnliche Arbeiten