FDA

Archive
13 April 2023

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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24 March 2023

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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25 November 2022

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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26 February 2018

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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22 April 2014

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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6 November 2013

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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6 November 2013

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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3 October 2013

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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23 January 2012

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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17 February 2011

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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