Rising demand for precision and personalized medicine has significantly augmented the need for artificial intelligence (AI)-enabled medical devices to deliver highly individualized diagnostics and ...

In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...

Katie Palmer covers telehealth, clinical artificial intelligence, and the health data economy — with an emphasis on the impacts of digital health care for patients, providers, and businesses. You can ...

On August 18, 2025, the Food and Drug Administration (FDA) issued guidance (Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device ...

AI in daily life quietly powers devices we interact with every day, from smartphones and home appliances to navigation apps and wearables. Edge computing and tiny neural networks embedded in device ...