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Industry news in brief

This Digital Health News industry roundup includes funding to trial gaming and AI tech to diagnose Alzheimer's and accreditation for
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AI platform designed to help diagnose stroke gains US regulatory approval

A platform which uses artificial intelligence to help clinicians identify certain types of stroke has received approval from the US
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Appropriate regulation

The regulation of healthcare apps emerged as a hot topic at the end of last year; and will be the
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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
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NHS England moves to regulate apps

NHS England is working with the US Food and Drug Administration on a bilateral framework for regulations on mobile health
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FDA issues rules on mobile health apps

The US Food and Drug Administration has issued its final guidance on how it will regulate mobile health apps.
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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
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Smartphone based ultrasound gets FDA go

A smartphone based ultrasound imaging system has been cleared by the US Food and Drug Administration.
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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
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Wearable cardiac sensor gets CE approval

An advanced new wearable wireless patient monitoring system has received CE mark approval, allowing it to be sold in Europe.
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