The emergence of artificial intelligence (AI) and machine learning (ML) can be seen across multiple industries, transforming everything from healthcare to transportation. Artificial intelligence has been in the spotlight recently, but it is not a new concept to the Food and Drug Administration (FDA) or the medtech industry. AI advancements in the medtech industry are playing a major role in improving patients’ lives through innovative care, reduced healthcare costs, and improved patient outcomes.
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Resource / Artificial Intelligence (AI) / Coverage & Payment / Digital Health / Regulatory Affairs
AdvaMed® Comment Letter to ASTP/ONC: Accelerating AI Adoption in Clinical Care
February 24, 2026
AdvaMed’s® Comment Letter to ASTP/ONC, outlines concrete policy reforms across FDA oversight, CMS payment pathways, and HIPAA data-sharing rules to accelerate patient access to AI-enabled medical technologies. As AI-enabled medical devices transform patient care, outdated regulatory, coverage, and privacy frameworks are slowing the pace of adoption.
News / Artificial Intelligence (AI) / Regulatory Affairs
i-GENTIC AI Launches Context-Aware MedTech Agents to Strengthen FDA 510(k) Submission Consistency
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PALO ALTO, Calif., Feb. 11, 2026 i-GENTIC AI today announced a new suite of context-aware, multilingual MedTech agents designed to help medical device manufacturers improve the quality and consistency of FDA 510(k) submissions. Preparing a 510(k) often takes months, yet many submissions require additional information requests or are rejected due to inconsistencies across documents, evidence, and claims, creating delays and added costs for manufacturers.
Blog / Regulatory Affairs
Why Practical FDA Submissions Training Makes the Difference
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Explore AdvaMed’s Medical Device Submissions Workshop Series from practical submission strategies to live expert insights you can apply immediately.
