Legacy medical devices face growing scrutiny as regulators push for stronger cybersecurity, transparency and risk management.

Opinion: Medical device companies can create a competitive advantage by leveraging data to strengthen compliance programs and ...

Like many in the medtech industry, I was initially optimistic when FDA announced its revised guidance on wearable wellness devices. For years, the industry has called for clearer, more predictable ...

The FDA’s oversight of medical device recalls continues to be plagued by staffing challenges—forcing some activities to be placed on the “back burner” and resulting in lengthy response times, ...

The FDA now accepts RWE for device submissions without needing identifiable patient data, facilitating the use of large, de-identified databases. This change addresses previous limitations that ...

Americans cannot rely on the Food & Drug Administration (FDA) to guarantee that medical devices are safe, and a recent Government Accountability Office (GAO) report only strengthens that conclusion.

The U.S. Food and Drug Administration (FDA) has issued warning letters to 30 telehealth companies citing false or misleading claims about compounded GLP-1 weight-loss products on their websites. The ...