Chinese-made medical devices pose an imminent threat, warn the FDA, CISA and the American Hospital Association. The federal government's cyber watchdog recently discovered a “backdoor” that can easily ...

Medical devices—whether compact, in-home tools like blood pressure monitors or large, sophisticated diagnostic systems used in hospitals and laboratories—are increasingly designed for global markets.

Draft guidelines from the European Commission aim to assist companies in determining whether their products, including medical devices that incorporate artificial intelligence (AI) components, are ...

Ransomware attacks on the healthcare sector surged by 30 percent in 2025, frequently disrupting operational technology and medical devices. FDA Section 524B mandates that manufacturers provide a ...