An FDA move to classify an iPhone image-viewing application as a Class III device that needs premarket approval could hinder the growing trend toward the use of mobile equipment for medical imaging. MIMvista, the company affected by the move, said it will go ahead with the PMA process for its Mobile MIM image-viewing and multimodality-fusion software for the iPhone. An FDA official said the agency has not yet issued a specific policy covering the use of hand-held devices for medical imaging.

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