The Current State of 521 FDA-Approved, AI-Based Medical Devices

The rise of Artificial Intelligence (AI) and Machine Learning (ML) in healthcare has reshaped the industry. And due to the recent march of ChatGPT, Midjourney and similar tools, various AI algorithms have entered the lives of the general population as well. These technologies will undoubtedly change the way medicine is practiced. Given that healthcare is an industry where decisions can literally be a matter of life and death, the importance of effective regulation can’t be overstated. Now this is one hell of a challenge even for the most seasoned professionals. AI and ML present novel regulatory challenges. Unlike traditional medical devices, these technologies are capable of evolving and learning over time. This means that they could perform differently in the real world than they did during their pre-market testing. While this could mean improved patient outcomes, it also could introduce new risks that need to be managed. Which is no easy task with a constantly changing algorithm.  Historically, the FDA has been a global pioneer in regulating novel technologies in healthcare. From pharmaceuticals to medical devices, the FDA was traditionally setting standards, no wonder, all eyes seem to be on the American regulatory body these days.  From zero to hero A few years ago the regulatory landscape for AI and ML technologies was almost non-existent. Medical device approvals didn’t explicitly indicate if a technology was AI-based. This made it...
Source: The Medical Futurist - Category: Information Technology Authors: Tags: Artificial Intelligence in Medicine AI digital health fda Healthcare AI in healthcare AI in medicine AI-based medical devices Source Type: blogs