Decoding AI in software as a medical device (SaMD)

Use of the term artificial intelligence has become ubiquitous across multiple sectors including medical devices. Although the FDA approved the first AI-enabled medical device in 1995, use of AI in medical devices stalled until 2015.  Since then, the number of medical devices using AI has increased rapidly with the FDA approving more than 1,000 such devices by March 2025. 

While there is not yet a unique FDA regulatory pathway, most AI-enabled devices follow a 510(k) pathway based on risk level and similarity to a predicate device. The remaining approvals have been granted on a De Novo basis.

This whitepaper provides a starting point for medical device researchers considering use of AI in SaMDs. Understanding the FDA regulatory requirements and guidance on submissions can enable medical device researchers to plan their route to market and avoid potential obstacles on the way.

Read our whitepaper to learn more about:

• AI in clinical applications, the difference between adaptive and locked AI
• Software as a medical device (SaMD) and software in a medical device (SiMD)
• Regulatory considerations for AI in SaMDs
• Real world examples of AI use in SaMDs and SiMDs