AI was a key theme at OCT Medical Devices 2025, yet human sensibility appears to be the true differentiator in clinical trial ...

What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.

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

In recent years, artificial intelligence (AI) has revolutionized the healthcare industry, accelerating the pace of medical breakthroughs and enhancing patient outcomes. From early disease detection to ...

For those with Class IIa or above AI-related devices, compliance with the EU’s AI Act is likely to be akin to the EU MDR.

Artificial intelligence (AI) and machine learning (ML) have already demonstrated tremendous potential to transform medicine, with almost 1,000 AI-enabled medical devices approved as of 2024 ...

Hospitals across the country are using artificial intelligence. See how guardrails vary from location to location.

Inequities that already exist in the healthcare system, and may be amplified by LLMs, could be addressed through the proving ground of artificial intelligence assurance labs, according to Brigham Hyde ...

Experts highlighted surgical robotics, artificial intelligence and M&A as top trends this year. However, the Trump administration could create challenges for the industry.

South Korea’s Ministry of Food and Drug Safety said it released the world’s first guideline on reviewing and approving generative artificial intelligence-based medical devices Jan. 24, to help ...

President Donald Trump rescinded the Biden administration’s sweeping executive order regulating artificial intelligence, ...