FDA moves to reclassify CAD software to class II

Developers of image analysis software such as computer-aided detection (CAD)...Read more on AuntMinnie.comRelated Reading:
FDA works on new regulatory framework for AI
FDA proposes new path to 510(k) clearance
FDA proposes ways to speed product approval
FDA issues new draft guidance for medical software, CDS
C-MIMI: FDA decision paves the way for imaging AI

Source: AuntMinnie.com Headlines - June 1, 2018 Category: Radiology Source Type: news