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FDAnews Device Daily Bulletin
July 17, 2012 | Vol. 9 No. 139
FDA Eases Some Clinical Trial Requirements for Imaging Devices
A pair of FDA final guidances may make it easier for companies to gain approval of devices that use computer software to analyze data gathered during radiology. Computer-assisted detection (CADe) devices analyze radiology to mark possible abnormalities. Under a clinical trial guidance released this month, study designs other than traditional field tests will be accepted as part of applications for new CADe systems.
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