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Understanding FDA cybersecurity requirements for medical devices and FCA enforcement
Key considerations for medical device manufacturers and how to prepare for a cybersecurity incident.
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Pharma Congress 2025: Monitoring off-label use
Panelists emphasized that the healthcare programs your organization wants to offer will get better results when closely monitored and constantly improved.
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FDA sends Whoop warning over Blood Pressure Insights wearable
The FDA claims Whoop is marketing an unauthorized medical device intended to diagnose, cure, treat or prevent a disease.
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FDA announces AI rollout timeline and scientific review pilot completion
The FDA said its timing to scale use of AI inside its FDA centers follows the completion of a GenAI pilot for scientific review.
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Is the new EU Health Data Space Regulation a turning point for EU health data access?
The regulation creates an EU health “data space” and is designed to facilitate access to and control of health data.
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UK’s MHRA launches consultation on regulation around medical devices
The process will look into four key areas, including UKCA marking, international reliance, In vitro diagnostic (IVD) devices and assimilated EU law.
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What you need to do as the EU AI Act gets a green light
A deal-readiness and compliance roadmap for dealing with the long-awaited proposals.