When a female patient received a pacemaker at the Frankel Cardiovascular Center at the University of Michigan, Ann Arbor, Michigan, and died shortly after with the brand-new and fully functioning device still in her chest, her grieving husband wondered whether the expensive and barely used technology could be donated to help someone else. Read more in […]
medical devices
Stronger rules needed for medical device cybersecurity
Experts say that health systems in the USA and other countries are not prepared for cybersecurity threats and existing and draft regulations are weak. The US Food and Drug Administration’s (FDA) latest draft guidelines for post-market management of cybersecurity risks in medical devices are a good start, but need to be given greater force to […]