US regulators have updated a guidance that details what software developers should consider when developing products used to detect anomalies in medical imaging, in response to an upcoming new order reclassifying medical-image analyzers.
The US Food and Drug Administration on 21 January republished its guidance on clinical performance for computer-assisted detection (CADe) devices used in radiology. The document was finalized in 2012 after the agency published a 2009 draft of the document following feedback from experts and the public. (Also see "US FDA explains clinical study, pre-market requirements for computer-assisted detection devices" - Medtech Insight, 6 July, 2012
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