Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent ...

Artificial intelligence is moving quickly into mainstream medical devices, and the industry has become fluent in a familiar set of concerns: bias, transparency, and cybersecurity. These topics matter, ...

The next phase of digital mental health adoption depends less on innovation and more on how the industry uses real-world evidence, builds reimbursement frameworks, and applies regulatory precedent to ...

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 ...

A recent survey of 2,000 UK patients found one in four patients (24%) already use AI for health guidance, and nearly one in three (30%) would be willing to consult AI or social media rather than wait ...

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