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 ...

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

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.

The two discussed the unique nature of the technology and its upcoming FDA approval. “I told him I’d be happy ... the spectral information of the backscattered light using an AI-powered algorithm. The ...

LONDON - IQ-AI Limited has shared a significant update on its operations, highlighting advancements in artificial intelligence (AI) for neuro-oncology and progress in a Phase One clinical trial for ...