Happify is launching a digital therapy designed to treat anxiety and depression. It has not yet been approved by the FDA, but the company is providing it through regulatory changes implemented by the Food and Drug Administration during the pandemic. Image source: Happify Health
After the US Food and Drug Administration relaxed guidelines for digital health products for the treatment of certain behavioral health conditions last year, the startup Happify Health is providing patients with app-based treatments for anxiety and depression.
The company’s new digital therapy is called Ensemble, and it uses app-based exercises to help people change negative thinking patterns and develop healthy habits. It has not been approved by the FDA and can only be obtained by prescription or through investigations and studies. Happify hopes to use it to obtain data for future regulatory submissions.
New York-based Happify has developed 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 established partnerships with multiple health plans and pharmaceutical companies.
Happify designed Ensemble using data from people who have used its app in the past eight years. Participants in this study will use the application for 10 weeks, completing 15 to 30-minute exercises twice a day under the guidance of a chatbot. Their progress is shared with their doctors through the dashboard.
Happify’s chief medical officer, Dr. Murray Zucker, stated in a press release that these activities are aimed at the underlying processes common to depression and anxiety. Although the app should help relieve symptoms, it is not intended to replace medication or therapy.
Happify is one of many mental health apps launched in recent years, and it is also one of the few companies that released software-based treatments in accordance with new FDA guidelines last year.
In April 2020, the agency Decided during the Covid-19 emergency, Developers can release “computerized behavioral therapy devices” and applications to treat mental illness without having to seek 510(k) permission. It is not yet clear how companies that provide products after the public health emergency will respond.
