establishing new standards for artificial intelligence (AI) safety and security, the US Food and Drug Administration (FDA) had been exploring how to regulate medical devices that incorporate AI ...

TORONTO—While the FDA has already doled out green lights to about 950 medical devices backed by artificial intelligence or ...

The FDA categorizes AI-enabled medical devices as types of SiMD or SaMD innovations. This patent lawyer provides practical ...

Different forms of artificial intelligence are having a substantial impact on the healthcare industry, and the use of AI is ...

Ceribell Inc., a medical-device maker that uses artificial intelligence to monitor patient seizures, was on track for a ...

The Advanced Research Projects Agency for Health says new funding to advance capabilities that detect and auto-correct misalignments with training data could help users of medical devices integrated ...

As I wrote previously, Precedence Research is forecasting the total addressable market for healthcare AI to reach $614 ...

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has put out a call for developers of artificial intelligence as a medical device (AIaMD) technology to join its new regulatory ...

On September 26, 2024, FDA published a compilation of commonly used terms in the digital health, artificial intelligence (AI), and machine ...

Examples range from ambient voice transcription tools that enable doctors or nurses to spend more time with their patients to diagnostic devices ... be seen how medical professionals and patients will ...