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 ...
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 ...
We reviewed 1016 FDA authorizations of AI/ML-enabled medical devices to develop a taxonomy capturing key variations in clinical and AI-related features. Quantitative image analysis remains the most ...
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