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Reclassification Order Spurs FDA To Update Computer-Assisted Detection Devices Guidance

To mesh with a final order reclassifying medical-image analyzers, the US agency has also published a final guidance on computer-assisted detection (CADe) devices that was first finalized more than six years ago.

3d rendering ai robot analyze x-ray brain tomography

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...

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