How AI-Powered Medical Devices Are Transforming M&A Agreements

Serdar HocamAuthor & Editor

As AI-powered medical devices become an integral part of clinical processes, they bring new procurement challenges for strategic buyers, such as data ownership and patents.

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COMMENTARY: How clinical integration is impacting deal terms for AI-enabled medical devices

The growing critical role of AI-powered medical devices in clinical workflows offers new opportunities for strategic buyers while also introducing various procurement challenges. In 2025, the Food and Drug Administration (FDA) approved 295 artificial intelligence and machine learning-based medical devices.

Strategic buyers competing for artificial intelligence and machine learning-enabled technologies face a series of new risks, such as data ownership, algorithmic drift, interoperability dependencies, and complex patent considerations. Legal experts Douglas Gray, Joseph Kadlec, and Rusty Close point out how buyers must evaluate these unique risks and how deal structures, due diligence protocols, and indemnifications must be adapted accordingly.

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