Revised guidance aligns with quality management system regulation changes and provides recommendations for cyber device submissions under section 524B of the FD&C Act.
New AI cybersecurity guidance is set to roll out in early 2026, as AI becomes more embedded in healthcare technology.
The US Department of State is offering up to $11 million for information leading to the arrest of Volodymyr Tymoshchuk, accused of deploying ransomware that targeted hospitals, companies, and major industrial firms
Illumina has agreed to pay $9.8 million after allegations that its genomic sequencing systems sold to federal agencies contained cybersecurity vulnerabilities.
Breakdowns in linking requirements to design, risk, and verification are fueling software errors, compliance gaps, and costly recalls across device categories.
A patient using a defibrillator died at a southern-based medical center after the device erupted in fire and burned his body.
Managed from an Apple iPad, the system is designed to maintain visitor check-in, logging, and badge printing functions even during internet or power outages.