Search Results for mHealth

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Wearable Technologies and Mobile Health Devices: Changing Medical Research and Delivering Better Patient Outcomes By Dr Elin Haf Davies, Chris Tyson - Published 28 August 2017

This article discusses how wearable technologies and mobile health devices are changing medical practice and improving patient outcomes with the potential to lower research and development costs and impact reimbursement.

Categories: Features, FDA, Medical Devices

Tags: Wearables, Mobile Health, mHealth, Patient Reported Outcomes

Apple Continues Push Into Device Industry With New Patent Filing By Zachary Brennan - Published 14 August 2017

Last week, tech behemoth Apple signaled its interest in further pursuing the development of medical devices with a new patent granted for an electronic device that "computes health data."

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Apple, iPhone, mHealth, digital health

FDA Declares ‘General Wellness’ Devices Exempt From Regulations By Michael Mezher - Published 28 July 2016

The US Food and Drug Administration (FDA) on Thursday finalized guidance saying that it does not plan to review low-risk "general wellness products", such as wearable fitness monitors or sleep trackers and will not require them to comply with premarket and postmarket regulatory requirements.

Categories: News, US, FDA, Government affairs, Medical Devices, Postmarket surveillance, Submission and registration

Tags: medical device regulation, health apps, mobile medical apps, mhealth, exercise equipment and FDA

Industry Calls for More Guidance From FDA on New Clinical Trials Technology By Zachary Brennan - Published 11 May 2016

The initiation of a new era of mobile health technology has erupted into industry calling on the US Food and Drug Administration (FDA) to offer more guidance on how best to use new technology, like Fitbits and mobile apps, in clinical trials, and to find ways that don’t restrict the development of novel tech products.

Categories: News, US, FDA, Clinical, Government affairs, Medical Devices, Research and development

Tags: Fitbit, mHealth, Medidata, Pfizer, GlaxoSmithKline, mobile health technology

FDA Collaborates With FTC on Mobile Health App Regulatory Tool By Zachary Brennan - Published 05 April 2016

The US Food and Drug Administration (FDA), the Federal Trade Commission (FTC) and other regulators are looking to help health-related mobile application developers comply with the Federal Food, Drug and Cosmetics Act (FD&C Act) and other applicable laws.

Categories: News, US, FDA, FTC, Business Skills, Compliance, Government affairs, Medical Devices

Tags: mHealth regulation, mobile health apps, health applications

EU Looks to Improve Data Quality of mHealth Apps By Zachary Brennan - Published 25 January 2016

The European Commission is bringing together a working group to develop guidelines by the end of 2016 for assessing the validity and reliability of the data that mobile health (mHealth) applications collect and process in order to make these ubiquitous apps more useful for public health.

Categories: News, Europe, US, EC, FDA, MHRA, Due Diligence, Government affairs, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: mHealth, mobile health apps, mobile health app data, mHealth regulations