INSIDE COMPLIANCE

Imagine a patient suffering from sporadic unconsciousness is hooked up to a heart monitor. Suddenly, an irregular heart rhythm begins but is flagged almost instantaneously. The irregularity was not spotted by a cardiologist analyzing an EKG but rather by AI trained on millions of other heartbeats. That’s not a scene from the future. It’s already routine. 

The FDA has authorized the marketing of over 1,500 AI-enabled medical devices in the United States. The first one dates back to 1995, but the number of devices has sharply increased since then and continues to do so. However, the main caveat for AI devices is that their software can change after authorization, but the FDA’s monitoring of those changes doesn’t. In light of this, the FDA needs stricter and more continuous regulation of AI-enabled medical devices.