FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers ...

Early recognition and mitigation of drug and device integration difficulties are critical to the success of combination ...

This article explains why Latin Americas demographic diversity, cost profile, and accelerating digital health infrastructure ...

This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for ...

The FDA has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025.

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

Recent advances in AI, including machine learning, natural language processing, and deep learning models, are transforming rare disease diagnosis.

In early December, the FDA issued final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled device software functions. This article shares the 13 key takeaways, including differences ...

Surgical navigation and robotic systems are not novel technologies, but the market continues to grow in the United States. Growth rates per clinical application varies.

Recently, Latin America has emerged as a promising frontier for medical device clinical trials, with Chile at the forefront of this development. The country's robust healthcare infrastructure and fast ...