Legacy medical devices face growing scrutiny as regulators push for stronger cybersecurity, transparency and risk management.
Key Takeaways - The FDA has identified a Class I recall (its most serious type) involving certain FreeStyle Libre 3 and ...
Opinion: Medical device companies can create a competitive advantage by leveraging data to strengthen compliance programs and ...
This three-part series reviews how the Food and Drug Administration’s (FDA) January 2026 guidance, “General Wellness: Policy ...
FDA plans to limit the regulation of wearable medical devices, according to a January 6 notice from the agency. Currently, the majority of fitness tracking wearables and fitness apps are classified as ...
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 ...
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