FDA clears first AI-based MRI super-resolution product, sparking safety debate

FDA cleared the first AI-based MRI super-resolution product; same company had PET approval. Blog raises safety concerns: 'denoising' may hallucinate details, and validation is lacking. Urges caution before clinical use.

• The FDA cleared an AI-based MRI super-resolution (denoising) product from a company that previously received clearance for a similar PET denoising product.
• The author highlights safety risks, including the potential for AI to generate false image details (hallucination), and criticizes the absence of rigorous prospective validation in the clearance process.
• This clearance is discussed as a case study in the broader need for robust safety evidence for AI-based image enhancement before widespread clinical adoption.

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