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

As AI in the medical device space rises, it likely means 2025 will be another challenging year for cyber threats in ...

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

AI-driven triage systems powered by ChatGPT have been designed to assess symptoms, suggest potential diagnoses, and recommend ...

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.

Today's medical AI systems represent not just a new diagnostic tool, but a new kind of medical reasoning altogether, writes ...

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.

KFDA sets global standard for generative AI medical device approval guidelines Health authority introduces pioneering ...

Guo has not only been about software and assay development but also about identifying new drugs and new indications for existing drugs for the treatment of lung cancer and breast cancer. Through the ...

With GE Healthcare’s AI-powered portable ultrasound, trained clinicians can perform detailed heart scans right at the bedside ...

My primary care physician has been using an AI-assisted device during our office visits that transcribes and records our ...