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FDA Reclassifies Medical Imaging Analyzers

January 21, 2020

The FDA issued a final order to reclassify certain radiological medical image analyzers, including computer-assisted detection (CADe) devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection devices, from Class III devices to Class II devices. 

The final order reclassifies certain CADe devices from Class III to Class II devices, subject to premarket notification. It also requires special controls to provide a reasonable assurance of safety and effectiveness for the devices.

The agency is also streamlining review for these types of computer-assisted detection devices in a move to give patients more timely access to the devices.

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