Today, adoption of digital health faces some of the same barriers — scepticism, budget limitations, high expectations, and a ...

Federal officials on Thursday approved a new type of pain pill designed to eliminate the risks of addiction and overdose ...

The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.

Discover the intricate process of crafting a diesel engine’s impeller using scraped aluminium, molded through traditional sand casting techniques. Skilled workers carefully mold the material, turning ...

As the regulatory landscape for in vitro diagnostics (IVDs) continues to shift, MDC Associates is at the forefront of adapting strategies to navigate the evolving 510(k) submission process.

After the rejection of Hutchmed’s treatment, despite the efforts to include a bridging trial, the FDA seems to have drawn a line in the sand, effectively requiring multiregional clinical trials ...

W. Edwards Deming Quality culture is a cornerstone of any industry, particularly the healthcare industry where patient lives ...