Mobile healthcare, telemedicine, telehealth, BYOD

mHealth and the FDA

FDA Reviews Mobile Health Platform for Autism Diagnosis, Care

February 26, 2018 - Federal regulators are moving toward approval of a mobile health platform designed to help doctors diagnose autism more quickly – and to help parents learn how to care for autistic children. The U.S. Food and Drug Administration recently ruled that software developed by Cognoa is a Class 2 diagnostic medical device, enabling the four-year-old, Palo Alto-Calif.-based mHealth...

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FDA OKs mHealth App That Uses AI to Spot Strokes, Alert Specialists

by Eric Wicklund

Federal regulators have approved an mHealth app that uses artificial intelligence to analyze CT images for signs of a stroke, potentially speeding up the time to treatment. The U.S. Food and Drug Administration has cleared for marketing...

The Future of mHealth May be Health Industry Collaboration

by Sara Heath

mHealth stakeholders may wish to consider investing in partnerships with other members of the health IT industry, suggests a new white paper from the law firm Hogan Lovells in partnership with the EBD Group. According to the report, the...

FDA Urged to Speed Up its mHealth Reviews

by Eric Wicklund

A coalition of healthcare IT organizations is urging the U.S. Food and Drug Administration to change the way it reviews new technology, including mHealth. The Clinical Decision Support Coalition, described as a “diverse group of...

FDA Steps Back from ‘Low Risk’ mHealth Regulation

by Eric Wicklund

Federal officials won’t regulate activity trackers and other mHealth devices and apps that focus on “general wellness” – though they may intervene if the products in question touch on clinical applications. The...


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