Generative AI in Healthcare Blogs & Thought Leadership

FDA’s QMSR Is Live: Why Clinical AI Teams Need Inspection-Ready Eviden...
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Enes HOSGOR
CEO at Gesund.ai
Apr 2, 2026
· min read
The FDA Radiology AI Debate Exposed the Next Big Gap in Clinical AI: I...
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Enes HOSGOR
CEO at Gesund.ai
Mar 23, 2026
· min read
Case Study: Prenuvo Achieves FDA Clearance with GDAP — The Assurance P...
Prenuvo achieved FDA clearance for its Body Composition AI using Gesund.ai’s GDAP — the regulatory-g...

Enes HOSGOR
CEO at Gesund.ai
Oct 15, 2025
· min read
FDA’s AI PCCP Update: From August  2024 Baseline to AI Specific Submis...
In August 2024, FDA issued a cross cutting draft on Predetermined Change Control Plans (PCCPs) for a...

Enes HOSGOR
CEO at Gesund.ai
Sep 3, 2025
· 8 min read
State AI Laws Are Now Setting the Rules for Healthcare AI: Here’s What...
U.S. states moved from exploratory AI bills to enforceable rules. In 2024–2025, several states enact...

Enes HOSGOR
CEO at Gesund.ai
Aug 13, 2025
· 12 min read
FDA’s New Regulatory Accelerator Forces a Rethink of AI Submission Str...
On July 2025, the FDA launched its Regulatory Accelerator, a curated hub of tools, guidance, and a b...

Enes HOSGOR
CEO at Gesund.ai
Aug 6, 2025
· 8 min read