This week on MedTech Global Insights, we dissect the FDA's surprising new focus on AI-powered medical devices. A recent public enforcement action has sent a clear message: pre-market approval is no longer enough. The agency is now intensely scrutinizing the hidden risks of post-market cybersecurity and algorithm performance.

We break down what this regulatory shift means for MedTech innovators worldwide. From the challenge of 'data drift' to the unseen vulnerabilities in routine software updates, we explore the new compliance traps that can derail even the most promising technologies after they have launched successfully.

**Case Study:** Imagine your revolutionary AI diagnostic tool, already approved and used by hospitals, is suddenly flagged by regulators for a cybersecurity flaw in its connection to a hospital's network. This isn't a hypothetical; it's the new reality companies are facing. We discuss how to prepare for this before it becomes a crisis.

**What You'll Learn:**

- Why is the FDA shifting its focus from pre-market approval to post-market vigilance for AI devices?

- What is 'algorithm drift' and why is it now a top regulatory concern?

- How can a seemingly minor software update trigger a full regulatory review?

- What are the essential cybersecurity documents you must have ready for auditors at all times?

- Are your current post-market surveillance plans adequate for AI-driven software?

- How do you prove your device is secure when connected to third-party hospital systems?

- What lessons can we learn from the EU's parallel approach to AI regulation?

- Is your technical dossier prepared for this new, continuous level of scrutiny?

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