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When the Algorithm Is a Device: AI, the FDA, and the Question Almost Nobody Is Asking
The AI tool you bought last quarter, the one bundled into your EHR upgrade, the one your hospital piloted on your unit. Was it cleared by the FDA as a medical device? Most physicians do not know the answer. In this episode of The Clinical Realist, Dr. Sarah Matt walks listeners through three questions: when is an AI tool a medical device, what do the three FDA approval pathways (510(k), De Novo, PMA) actually mean about the evidence behind a product, and what does professional liability look like when the algorithm is the one making the call. Book a Discovery and Clarity Session: calendly.com/sarahmattmd
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Resources & Links:
📖 Get the Book: "The Borderless Healthcare Revolution" is available now on Amazon and major retailers.
💼 Work with Dr. Matt:
Looking for a keynote speaker or strategic advisor?
Visit: drsarahmatt.com
🔗 Connect on Social:
LinkedIn: https://www.linkedin.com/in/sarahmattmd/
YouTube: https://www.youtube.com/@DrSarahMatt-ClinicalRealist
📧 Subscribe to The Briefing: drsarahmatt.com/newsletter-signup
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Disclaimer:
The views expressed on this podcast are those of Dr. Sarah Matt and her guests. They do not necessarily reflect the official policy or position of any affiliated institutions. This content is for informational and educational purposes only and does not constitute medical advice or a professional consulting relationship.
View all episodes
By Dr. Sarah MattThe AI tool you bought last quarter, the one bundled into your EHR upgrade, the one your hospital piloted on your unit. Was it cleared by the FDA as a medical device? Most physicians do not know the answer. In this episode of The Clinical Realist, Dr. Sarah Matt walks listeners through three questions: when is an AI tool a medical device, what do the three FDA approval pathways (510(k), De Novo, PMA) actually mean about the evidence behind a product, and what does professional liability look like when the algorithm is the one making the call. Book a Discovery and Clarity Session: calendly.com/sarahmattmd
—
Resources & Links:
📖 Get the Book: "The Borderless Healthcare Revolution" is available now on Amazon and major retailers.
💼 Work with Dr. Matt:
Looking for a keynote speaker or strategic advisor?
Visit: drsarahmatt.com
🔗 Connect on Social:
LinkedIn: https://www.linkedin.com/in/sarahmattmd/
YouTube: https://www.youtube.com/@DrSarahMatt-ClinicalRealist
📧 Subscribe to The Briefing: drsarahmatt.com/newsletter-signup
—
Disclaimer:
The views expressed on this podcast are those of Dr. Sarah Matt and her guests. They do not necessarily reflect the official policy or position of any affiliated institutions. This content is for informational and educational purposes only and does not constitute medical advice or a professional consulting relationship.