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www.fdanews.com/articles/205494-digital-therapeutic-for-alcohol-abuse-deemed-breakthrough-device

Digital Therapeutic for Alcohol Abuse Deemed Breakthrough Device

November 24, 2021

Boston, Mass.-based Pear Therapeutics’ digital therapeutic for alcohol abuse has been designated a breakthrough device by the FDA.

The reSET-A investigational device is the latest in a line of virtual addiction therapeutic devices from the company that deliver cognitive behavior therapy, allowing users to track their progress using an app on their smartphone or tablet.

Approximately 14 million adults age 18 and up in the U.S. had alcohol use disorder in 2019, but fewer than one in 10 who had had the diagnosis for 12 months or more were getting any treatment, the company said.

The FDA previously cleared two similar products from the company designed to treat substance use disorder and opioid use disorder.

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