Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

Any patient can access Signos' system, which uses an AI platform and an off-the-shelf continuous glucose monitor, or CGM, ...

Signos announced today that it launched its FDA-cleared over-the-counter glucose monitoring system for weight management.

The ArteraAI prostate test uses artificial intelligence and biomarkers to predict if standard hormone therapy will be ...

The approval of ArteraAI Prostate by the FDA as a software as a medical device (SaMD) means it can now be used at the point ...

The FDA’s AI program needs to have guardrails in place to ensure it’s working properly. No matter what AI is used for at the FDA, processes must be in place to ensure fairness and accuracy ...

In a series of tweets in April, FDA Commissioner Scott Gottlieb, MD, wrote the agency is working toward a new regulatory approach to promote the use of AI algorithms that diagnose and treat diseases.

There is an immediate need for a new, agile process that helps everyday people find safe and trustworthy mental health AI ...

Walmart recalls shrimp in 13 states after FDA finds radioactive contamination. OpenAI challenger Manus hits $90M revenue run ...