Stay Up to Date with Medical AI Regulations

Get the latest news and updates about AI regulations, all in one place.

In medical AI, precision isn't optional, it’s foundational. Creating high-qualit...

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Dr. Sumir Patel

Chief Medical Officer at Gesund.ai

Jul 29, 2025

· 8 min read

EU AI Act Is Now Law: What Healthcare AI Leaders Must Do in 2025

Europe’s Artificial Intelligence Act (Regulation (EU) 2024/1689) entered into force in August 2024 a...

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Enes HOSGOR

CEO at Gesund.ai

Jul 9, 2025

· 10 min read

First CE Certified Large Language Model for Clinical Decision Support: What Prof. Valmed’s Class IIb Approval Signals for Regulatory Grade Healthcare AI

Prof. Valmed has become the first LLM powered clinical decision support (CDS) system to win a Class ...

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Enes HOSGOR

CEO at Gesund.ai

Jul 2, 2025

· 10 min read

Medical Superintelligence Arrives: What Microsoft’s MAI DxO Means for Regulatory Grade Healthcare AI

Microsoft’s new Medical AI Diagnostic Orchestrator (MAI DxO) claims 85 % accuracy on 304 of the New ...

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Enes HOSGOR

CEO at Gesund.ai

Jul 2, 2025

· 8 min read

The AMA & Manatt AI Governance Toolkit: A Blueprint for Responsible AI in Healthcare

The American Medical Association, in partnership with Manatt Health, released a first-of-its-kind AI...

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Enes HOSGOR

CEO at Gesund.ai

Jun 25, 2025

· 9 min read

FDA Ends Animal Testing: It’s not Just Ethical, It’s Strategic. Here’s What Comes Next for Pharma and AI

In a transformative shift, the FDA announced plans to phase out animal testing requirements for mono...

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Enes HOSGOR

CEO at Gesund.ai

Jun 20, 2025

· 8 min read

The FDA Is Now Using Generative AI to Review Drugs and Devices. Here’s What That Means for You.

In a bold move that underscores how seriously it takes artificial intelligence, FDA is rolling out a...

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Enes HOSGOR

CEO at Gesund.ai

Jun 10, 2025

· 7 min read

Biden and AI Governance: The Case for a Hub-and-Spoke Framework in Model Validation

Amid rapid AI adoption across critical sectors, the U.S. government is taking steps.....

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Enes HOSGOR

CEO at Gesund.ai

Jan 3, 2024

· 8 min read

The New Section 1557 Rule: AI Compliance in Healthcare Just Became a Strategic Imperative

As of May 1, 2025, hospitals and health plans must comply with the revised Section 1557... ...

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Gesund.ai

May 18, 2025

· 10 min read

Walking The Walk: Gesund Achieves SOC 2 - Type II Compliance, The Highest Standard for Data and IT Security

Gesund.ai is proud to announce that we’ve received a clean SOC 2 - Type II attestation report. ...

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Gesund.ai

May 30, 2023

· 3 min read