FDA

Appropriate regulation

Appropriate regulation

The regulation of healthcare apps emerged as a hot topic at the end of last year; and will be the subject of a lively discussion at the HANDI spring symposium that forms part of EHI’s Digital Health Festival. Lis Evenstad reports.


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Med device regulation not fit for apps

Med device regulation not fit for apps

Medical apps need a better safety assurance process, but applying the processes applied to the regulation of medical devices may not be the way forward, the HANDI Health Apps conference has been told.


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Is there a regulation for that?

Is there a regulation for that?

Apps are flooding into the healthcare market. But regulators are struggling to catch up – and many people in the industry don’t want them involved. Shanna Crispin reports.


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FDA clears Cerner CareAware iBus

Cerner has received US Food and Drug Administration (FDA) clearance for a new product that enables exchange of information between medical devices and electronic health records.


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FDA clears Carestream Health product

The US Food and Drug Administration has given marketing clearance to the DRX-1 System from Carestream Health. The company claims the DRX-1 is the industry’s first wireless digital radiography detector, and that now it has FDA clearance it will start taking orders and shipping within weeks. The system incorporates a console and a wireless cassette-sized […]


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