Happify rolls out digital therapeutic for anxiety, depression under temporary FDA guidance

Happify is rolling out a digital therapeutic designed to treat anxiety and depression. It’s not yet FDA-cleared, but the company is making it available through a regulatory change implemented by the Food and Drug Administration during the pandemic. Photo credit: Happify Health

After the Food and Drug Administration loosened guidelines last year for digital health products treating some behavioral health conditions, startup Happify Health is making an app-based treatment for anxiety and depression available to patients.

The company’s new digital therapeutic, called Ensemble, uses app-based exercises to help people change negative thinking patterns and develop healthy habits. It’s not FDA cleared, and is only available by prescription or through an investigational study. Happify plans to use real-world data to submit its product for clearance in the next 18 to 24 months, head of digital therapeutics Chris Wasden wrote in an emailed statement.

New York-based Happify already built an app that uses games and activities to help people with negative thoughts and stress. It raised $73 million in funding earlier this year, and has struck partnerships with multiple health plans and pharmaceutical companies.

Happify designed Ensemble using data from people who have used its ’s app over the last eight years. People who participate in the study will use the app for 10-weeks, completing two 15- to 30-minute exercises each day, while guided by a chatbot. Their progress is shared with their physician through a dashboard.

Dr. Murray Zucker, Happify’s chief medical officer, said in a news release that the activities were designed to target underlying processes that are common to both depression and anxiety. Although the app is supposed to help with symptoms, it’s not intended to replace medication or therapy.

Happify is one of a multitude of mental health apps that have become available in recent years, and one of a handful of companies that have released software-based treatments in the last year under the FDA’s new guidance.

In April of 2020, the agency decided that during the Covid-19 emergency, developers could release “computerized behavioral therapy devices” and apps to treat psychiatric disorders without seeking 510(k) clearance. It’s not yet clear how companies who have made products available will navigate this after the public health emergency ends.

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