The healthcare industry faces an unprecedented cybersecurity crisis as connected medical devices proliferate at an alarming rate. With predictions that over seven million Internet of Medical Things ...
A popular medical monitor is the latest device produced in China to receive scrutiny for its potential cyber risks. However, it is not the only health device we should be concerned about. Experts say ...
In conversations about medical device cybersecurity, attention focuses on the Food and Drug Administration’s (FDA) rules and guidelines. With a refresh in 2023 that emphasized new protocols for ...
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 ...
The Food and Drug Administration designates as “breakthrough” technologies certain drugs and devices. This designation helps expedite the development and review of therapies intended to treat serious ...
Fueled by convenience, fashion, size and technical innovation, medical devices have evolved from clinical settings to daily consumer use. Today’s highly personalized devices are being embedded into ...
Globally, generative artificial intelligence (Gen AI) and agentic AI are increasingly being integrated into medical devices, transforming both clinical workflows and patient care. Gen AI is primarily ...
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 ...