Abiomed identified quality issues, including purge cassette recognition failures and unreliable buttons, that could delay therapy or cause loss of hemodynamic support.
Hospitals and medical device manufacturers have more cybersecurity guidance and requirements than ever, but third-party attacks, AI-assisted vulnerability discovery, and aging equipment continue to complicate efforts to reduce risk.
How to update cybersecurity assessments and controls between scheduled reviews.
The project adds 40,000 square feet to Siemens Healthineers’ sole global manufacturing site for PET detectors used in its PET/CT scanners.
