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Happify Health Launches Prescription Digital Therapeutics To Treat Depression Or Anxiety

 
• By Marion Webb

After raising $73m in a series D in March, Happify Health is recruiting patients in a real-world study to further evaluate its behavioral health app.

Depression

Happify Health will launch a new investigational prescription-only software called Ensemble as an adjunct therapy for treating major depressive disorder or generalized anxiety disorder, the New York-based company announced on 21 July. The company will conduct clinical studies with a pathway seeking 510(k) clearance from the US Food and Drug Administration.

“The product will be launched as an investigational device where we will be running a real-world evidence study on patients that use it and [we will be] using that data that we collect from the study for the FDA filing [under the software-as-medical devices

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