FDA

Archive

HearO app uses AI to predict heart failure deterioration

The HearO app from Cordio Medical is set to expand into the UK this year, helping congestive heart failure patients
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Industry news in brief

This Digital Health News industry roundup covers Maven Clinic’s acquisition of Naytal and Medwise.ai securing a £1m investment to scale
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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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