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Zdrowie i gospodarka · 13/06/2025

FDA Classifies Radiological Computer-Assisted Detection and Diagnosis Software as Class II Device

The FDA has classified radiological computer-assisted detection and diagnosis software as a Class II device, subject to special controls, to ensure safety and effectiveness, and to reduce regulatory burdens, ultimately enhancing patient access to innovative devices.

Source: Federal Register — Food and Drug AdministrationOpen original release →