While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025.

A recent survey of 2,000 UK patients found one in four patients (24%) already use AI for health guidance, and nearly one in ...

In the current Cyber Threat environment, companies must have strong cyber liability insurance. Policies must specifically account for cyber-physical risks and the substantial costs of post-market ...

omico’s new facility expands its global production capacity and enhances its ability to be close to customers without taking ...

The initial fear that the artificial intelligence and machine learning evolution will replace humans is shifting. A new narrative recognizes the potential for an AI-enabled workforce — one where the ...

The 2025 Medtech Regulatory Affairs Benchmark reveals that many medtech companies lack confidence in their data’s completeness or accuracy and still rely heavily on manual processes to maintain ...