mHealth Intelligence September 28, 2017
Eric Wicklund

mHealth companies large and small, from Apple and Fitbit to Pear Therapeutics and Tidepool, are named to the FDA’s new digital health pilot program. They represent a broad range of mobile health innovation.

Smartphones, wearables, mHealth apps and even digital therapeutics will all get equal play in the U.S. Food and Drug Administration’s new digital health software precertification pilot program.

FDA Commissioner Scott Gottlieb this week unveiled eight digital health companies, both large and small, that will take part in the program, designed to “inform a tailored approach toward digital health technology by looking at the software developer or digital health technology developer, rather than primarily at the product.”

“Our method for regulating digital health products must recognize the unique...

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