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 a clinical AI platform.
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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 Food and Drug Administration (FDA).
AI and Analytics
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
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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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 apps.
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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 industry don’t want them involved. Shanna Crispin reports.
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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 medical devices and electronic health records.
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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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