Since AI was added to the device, the FDA has received unconfirmed reports of at least 100 malfunctions and adverse events.

In 2021, a unit of healthcare giant Johnson & Johnson announced “a leap forward”: It had added artificial intelligence to a ...

For decades, Parkinson’s disease has been diagnosed only after tremors, stiffness and slowed movement are already disrupting daily life. Now a wave of research suggests a simple blood draw could ...

AI-powered medical devices are linked to injuries, recalls, and lawsuits as regulators struggle to oversee a fast-growing ...

At least 1,357 medical devices using AI are now authorized by the FDA – double the number it had allowed through 2022 ...

Medical device makers have been rushing to add AI to their products. While proponents say the new technology will ...

Think about the last time you searched for something specific—maybe a product comparison or a technical fix. Ideally, you ...

If you’ve opened Google recently and felt like you were assigning a task to an assistant rather than typing keywords into a box, you aren’t alone. The ...

Key Takeaways - FDA’s 2026 guidance clarifies when digital health tools fall outside device regulation. Updated policies for clinical decision ...

Africa has 11 percent of the world’s population and 24 percent of the global disease burden, yet only 3 percent of the world’s health workers and less than 1 percent of global health expenditure.

Traumatic spinal cord injury (SCI) is a serious neurologic disorder that can result in long-term motor and sensory ...

AI agents left alone are building religions, writing scripture and scheming against each other. What they do when no one is watching reveals what we've forgotten.