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RapidAI announced that it received FDA 510(k) clearance for its Lumina 3D automated 3D imaging reconstruction solution.

On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...

Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...

GE HealthCare Technologies Inc. GEHC recently announced receiving FDA 510(k) clearance for its updated Voluson Expert Series ...

New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain ...

More than 10 million babies have been born through IVF, yet the process is still invasive and costly. Plus, why a venture ...

The words “artificial intelligence” are now ubiquitous, their influence having risen dramatically in recent years and their ...

Congenital heart defects (CHDs) are the most common birth defect, affecting nearly 1 in 100 newborns. In the United States, ...

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.

Results from the study assisted Notal Vision in receiving De Novo authorization from the US FDA for the SCANLY Home OCT in ...

2025 /PRNewswire/ -- AI Optics Inc., an AI-focused medical device company announced today that it has received FDA 510(k) clearance for its Sentinel Camera. This handheld retinal imaging system ...