The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.

HeartBeam (NASDAQ: BEAT) , a medical technology company advancing cardiac care, has submitted a 510 (k) application to the U.S. Food and Drug Administration (“FDA”) for its 12-lead electrocardiogram ( ...

The FDA has approved nearly a thousand artificially ... look at the performance of a model of an algorithm, AI-enabled or not, when it’s deployed.” Perhaps the most common AI product in ...

For AI models that FDA determines are high risk ... same will hold true when the tool is an AI/ML based algorithm that may well need approval in its own right. It is also worth noting that ...

This system is set to benefit from Anumana's ECG-AI LEF algorithm, which is approved by the US Food and Drug Administration (FDA) and uses routine 12-lead ECG data to identify left ventricular ...

Research co-led by University of Toronto researchers and Insilico Medicine has demonstrated the potential of quantum ...

Artificial intelligence systems require consistent monitoring and staffing to put in place and to keep them working well.

Despite increasing awareness, identifying and mitigating the effects of ACEs remains a significant challenge, particularly ...

Eko sells a range of digital stethoscopes and already has two FDA-approved AI algorithms for other cardiac features, one for atrial fibrillation (AF) and another for structural murmurs associated ...

Artificial intelligence start-up Quibim has raised $50 million in first-round financing to support the rollout of its ...