The conversation around AI in healthcare is changing. The question is no longer whether AI can support clinical decision-making. The question is how regulators, developers and healthcare systems can ensure these technol...

Obesity studies face a growing paradox: demand for trial participation has never been higher, yet attrition remains one of the biggest threats to study success. As therapies become increasingly differentiated, retention...

Healthcare is moving towards a future where AI-enabled technologies do more than identify disease. Increasingly, they are expected to support complex clinical decisions that can directly influence patient care. That sh...

What comes next for pivotal trial design in cell and gene therapies? As new and next generation therapies emerge, sponsors face increasingly complex questions around comparator selection, study feasibility and evidence g...

The PPWR introduces a long-term compliance framework that will impact medical device packaging well beyond 2026. Speaking with Medtech Insight, ICON regulatory SMEs Claudia Anzaldo and Véronique Boscher highlight the im...

Regulatory requirements continue to evolve across global markets. Keeping pace with changes from the FDA, EMA, MHRA, PMDA, NMPA and other health authorities is critical for successful product development and lifecycle ma...

More than half of FDA authorisations for AI-enabled software as a medical device have occurred since 2022. Radiology continues to dominate, but the future of AI-enabled healthcare extends far beyond imaging. The next gen...

For neurologic mAbs, approval and access aren't the same thing. For example, Medicare coverage for anti-amyloid Alzheimer's therapies depends on registry enrolment of each patient before the first dose is administered. R...

What could acceptance of biomarker-based surrogates mean for biotechs pursuing tumor-agnostic therapies? Find out more in our article exploring how liquid biopsy based biomarkers are being leveraged in tumor agnostic tri...

A meeting room looked a little different in our Buenos Aires office this week. Instead of presentations and project discussions, colleagues rolled up their sleeves to take part in a blood donation drive hosted on site. ...

The real promise of AI in healthcare is not the technology itself. It is the potential to help clinicians make better decisions, improve patient outcomes and deliver more personalised care. As AI-enabled medical devices ...

Global success starts long before a regulatory submission. In PharmaTimes Magazine, ICON discusses how APAC sponsors can design studies with global authorisation in mind, helping ensure clinical data meets the expectatio...